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  </head><body onload="reset_menus();"><div id="menu"><a name="top" class="invisible" href="#main">Skip Navigation Link</a><span class="study-name">CDISCPILOT01</span><ul class="hmenu"><li class="hmenu-item"><span class="hmenu-bullet">+</span><a class="external tocItem" href="acrf.pdf">Annotated CRF</a><span class="external-link-gif"></span></li><li class="hmenu-submenu"><span onclick="toggle_submenu(this);" class="hmenu-bullet">+</span><a class="tocItem">Supplemental Documents</a><ul><li class="hmenu-item"><span class="hmenu-bullet">+</span><a class="external tocItem" href="csdrg.pdf">Reviewers Guide</a><span class="external-link-gif"></span></li></ul></li><li class="hmenu-item"><span class="hmenu-bullet" onclick="toggle_submenu(this);">-</span><a class="tocItem" href="#Standards_Table">Standards</a></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#datasets">Datasets</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TA">TA (Trial Arms)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TE">TE (Trial Elements)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TI">TI (Trial Inclusion/Exclusion Criteria)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TS">TS (Trial Summary)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TV">TV (Trial Visits)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.DM">DM (Demographics)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SE">SE (Subject Elements)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SV">SV (Subject Visits)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.CM">CM (Concomitant Medications)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.EC">EC (Exposure as Collected)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.EX">EX (Exposure)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.AE">AE (Adverse Events)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.DS">DS (Disposition)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.MH">MH (Medical History)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.DD">DD (Death Details)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.FT">FT (Functional Tests)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.IE">IE (Inclusion/Exclusion Criteria Not Met)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.LB">LB (Laboratory Test Results)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.NV">NV (Nervous System Findings)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.OE">OE (Ophthalmic Examinations)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.QSPH">QSPH (Questionnaires (PHQ-9))</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.QSSL">QSSL (Questionnaires (SQLS))</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.RS">RS (Disease Response and Clin Classification)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.VS">VS (Vital Signs)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.FA">FA (Findings About Events or Interventions)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.RELREC">RELREC (Related Records)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPDM">SUPPDM (Supplemental Qualifiers for DM)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPEC">SUPPEC (Supplemental Qualifiers for EC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPNV">SUPPNV (Supplemental Qualifiers for NV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPOE">SUPPOE (Supplemental Qualifiers for OE)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.DI">DI (Device Identifiers)</a></li></ul></li><li class="hmenu-submenu"><span onclick="toggle_submenu(this);" class="hmenu-bullet">+</span><a href="#decodelist" class="tocItem">Controlled Terminology</a><ul><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#decodelist">CodeLists</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ACN">Action Taken with Study Treatment</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AEREL">Relationship</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AESEV">Severity/Intensity Scale for Adverse Events</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AGEU_YEARS">Age Unit in Years</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ARM">Arm</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ARMCD">Arm Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ARMNRS">Arm Null Reason</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AVL02TC">Rey Auditory Verbal Learning Test Functional Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AVL02TR">Rey Auditory Verbal Learning Test Functional Test Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AVL02TT">Rey Auditory Verbal Learning Test Functional Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DDTEST">Death Details Tests</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DDTESTCD">Death Details Test Codes</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DIPARM">Device Identifier Element Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DIPARMCD">Device Identifier Element Short Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_AE">SDTM Domain Abbreviation, subset used for Adverse Events</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_CM">SDTM Domain Abbreviation, subset used for Concomitant Meds</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_DD">SDTM Domain Abbreviation, subset used for Death Diagnosis</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_DI">SDTM Domain Abbreviation, subset used for Device Identifiers</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_DM">SDTM Domain Abbreviation, subset used for Demographics</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_DS">SDTM Domain Abbreviation, subset used for Disposition</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_EC">SDTM Domain Abbreviation, subset used for Exposure as Collected</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_EX">SDTM Domain Abbreviation, subset used for Exposure</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_FA">SDTM Domain Abbreviation, subset used for Findings About Events or Interventions</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_FT">SDTM Domain Abbreviation, subset used for Functional Tests</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_IE">SDTM Domain Abbreviation, subset used for Inclusion/Exclusion</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_LB">SDTM Domain Abbreviation, subset used for Laboratory Data</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_MH">SDTM Domain Abbreviation, subset used for Medical History</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_NV">SDTM Domain Abbreviation, subset used for Nervous System Findings</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_OE">SDTM Domain Abbreviation, subset used for Ophthalmic Examinations</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_QS">SDTM Domain Abbreviation, subset used for Questionnaires</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_RS">SDTM Domain Abbreviation, subset used for Disease Response and Clin Classification</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_SE">SDTM Domain Abbreviation, subset used for Subject Element</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_SV">SDTM Domain Abbreviation, subset used for Subject Visits</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_TA">SDTM Domain Abbreviation, subset used for Trial Arms</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_TE">SDTM Domain Abbreviation, subset used for Trial Elements</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_TI">SDTM Domain Abbreviation, subset used for Trial Inclusion/Exclusion Criteria</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_TS">SDTM Domain Abbreviation, subset used for Trial Summary</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_TV">SDTM Domain Abbreviation, subset used for Trial Visits</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DOMAIN_VS">SDTM Domain Abbreviation, subset used for Vital Signs</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DSCAT">Category for Disposition Event</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DSSCAT">Subcategory for Disposition Event</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ELEMENT">Element</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ENRTPT_CM_AE">Relation to Reference Period, subset used for AE and CM.</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.EPOCH">Epoch</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ETCD">Element Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ETHNIC">Ethnic Group Hispanic</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.EXTRT">Study Treatment</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FACAT">FA Category</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FAOBJ">FA Object</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FAOCCUR">Occurrence</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FASEV">Severity</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FATEST">Findings About Adverse Events Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FATESTCD">Findings About Adverse Events Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FREQ_CM">Frequency, subset used for CM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FREQ_ECEX">Frequency, subset used for EC and EX</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FRM_ECEX">Dose Form, subset used for EC and EX</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.FTCAT">Category of Functional Test, subset used for FTCAT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD101">Hamilton Depression Rating Scale - 17 Item - Question 1</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD101S">Hamilton Depression Rating Scale - 17 Item - Question 1 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD102">Hamilton Depression Rating Scale - 17 Item - Question 2</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD102S">Hamilton Depression Rating Scale - 17 Item - Question 2 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD103">Hamilton Depression Rating Scale - 17 Item - Question 3</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD103S">Hamilton Depression Rating Scale - 17 Item - Question 3 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD104">Hamilton Depression Rating Scale - 17 Item - Question 4</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD104S">Hamilton Depression Rating Scale - 17 Item - Question 4 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD105">Hamilton Depression Rating Scale - 17 Item - Question 5</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD105S">Hamilton Depression Rating Scale - 17 Item - Question 5 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD106">Hamilton Depression Rating Scale - 17 Item - Question 6</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD106S">Hamilton Depression Rating Scale - 17 Item - Question 6 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD107">Hamilton Depression Rating Scale - 17 Item - Question 7</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD107S">Hamilton Depression Rating Scale - 17 Item - Question 7 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD108">Hamilton Depression Rating Scale - 17 Item - Question 8</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD108S">Hamilton Depression Rating Scale - 17 Item - Question 8 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD109">Hamilton Depression Rating Scale - 17 Item - Question 9</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD109S">Hamilton Depression Rating Scale - 17 Item - Question 9 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD110">Hamilton Depression Rating Scale - 17 Item - Question 10</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD110S">Hamilton Depression Rating Scale - 17 Item - Question 10 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD111">Hamilton Depression Rating Scale - 17 Item - Question 11</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD111S">Hamilton Depression Rating Scale - 17 Item - Question 11 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD112">Hamilton Depression Rating Scale - 17 Item - Question 12</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD112S">Hamilton Depression Rating Scale - 17 Item - Question 12 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD113">Hamilton Depression Rating Scale - 17 Item - Question 13</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD113S">Hamilton Depression Rating Scale - 17 Item - Question 13 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD114">Hamilton Depression Rating Scale - 17 Item - Question 14</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD114S">Hamilton Depression Rating Scale - 17 Item - Question 14 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD115">Hamilton Depression Rating Scale - 17 Item - Question 15</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD115S">Hamilton Depression Rating Scale - 17 Item - Question 15 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD116A">Hamilton Depression Rating Scale - 17 Item - Question 16A</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD116AS">Hamilton Depression Rating Scale - 17 Item - Question 16A Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD116B">Hamilton Depression Rating Scale - 17 Item - Question 16B</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD116BS">Hamilton Depression Rating Scale - 17 Item - Question 16B Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD117">Hamilton Depression Rating Scale - 17 Item - Question 17</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD117S">Hamilton Depression Rating Scale - 17 Item - Question 17 Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD17C">Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.HAMD17T">Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.IECAT">Category for Inclusion/Exclusion</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.IETEST">Inclusion/Exclusion Criterion</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.IETESTCD">Incl/Excl Criterion Short Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.INTMODEL">Intervention Model Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.INTTYPE">Intervention Type Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LAT_OE">Laterality, subset to be used in OE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LBCAT">Laboratory Test Category</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LBTEST">Laboratory Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LBTESTCD">Laboratory Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LOC">Location</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LOC_OE">Anatomical Location, subset used for OELOC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LOC_VS">Anatomical Location</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.MHEVDTP">Medical History Event Date Type, subset used for MHEVDTP</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.MHTERM">Medical History Term</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.NCOMPLT">Completion/Reason for Non-Completion</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ND">Not Done</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.NORMABNM">Normal Abnormal Response, subset used in OE and NV.</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.NRIND">Normal Range Indicator</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.NVTEST">Nervous System Test</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.NVTESTCD">Nervous System Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.OEFOCUS">Ophthalmic Focus of Study Specific Interest</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.OEMETHOD">Method, subset used for OEMETHOD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.OETEST">Ophthalmic Exam Test</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.OETESTCD">Ophthalmic Exam Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.OUT">Outcome of Event</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PHQ01C">Patient Health Questionnaire - 9 Item Questionnaire Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PHQ01R">Patient Health Questionnaire Responses</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PHQ01RQ10">Patient Health Questionnaire Responses-Question 10</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PHQ01RS">Patient Health Questionnaire Responses Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PHQ01T">Patient Health Questionnaire - 9 Item Questionnaire Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.POSITION_VS">Position, subset to be used for VSPOS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PROTMLST">Protocol Milestone</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.QSCAT_PH">Category of Questionnaire for PHQ-9</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.QSCAT_SL">Category of Questionnaire for SWLS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.RACE">Race</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.RACEMULT">Race Multiple Selections</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.RDOMAIN_RELREC">SDTM Domain Abbreviation, subset used for RELREC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.RELTYPE">Relationship Type</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ROUTE_CM">Route of Administration, subset to be used for CM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ROUTE_ECEX">Route of Administration, subset to be used for EC and EX</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.RSCAT">Category of Clinical Classification, subset to be used for RSCAT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SEX">Sex Male Female</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SITEID">Site Identifier</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.STYPE">Study Type Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SWLS01TC">Satisfaction With Life Scale Questionnaire Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SWLS01TN">Satisfaction With Life Scale Questionnaire Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SWLSR">SWLS-Responses</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SWLSR_S">SWLS-Responses Standardized</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.TBLIND">Trial Blinding Schema Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.TCNTRL">Control Type Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.TINDTP">Trial Intent Type Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.TPHASE">Trial Phase Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.TSPARM">Trial Summary Parameter Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.TSPARMCD">Trial Summary Parameter Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.TTYPE">Trial Type Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_CM">Unit, subset to be used for CMDOSU</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_ECDOSU">Unit, subset to be used for ECDOSU</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_ECPSTRGU">Unit, subset to be used for ECPSTRGU</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_EX">Unit, subset to be used for EXDOSU</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_10^12/L">Unit, subset to be used in VLM for tests with 10^12/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_PCT">Unit, subset to be used in VLM for tests with % as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_fL">Unit, subset to be used in VLM for tests with fL as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_fmol">Unit, subset to be used in VLM for tests with fmol as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_g/L">Unit, subset to be used in VLM for tests with g/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_g/dL">Unit, subset to be used in VLM for tests with g/dL as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_mEq/L">Unit, subset to be used in VLM for tests with mEq/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_mIU/L">Unit, subset to be used in VLM for tests with mIU/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_mU/L">Unit, subset to be used in VLM for tests with mU/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_ng/L">Unit, subset to be used in VLM for tests with ng/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_pg">Unit, subset to be used in VLM for tests with pg as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_pmol/L">Unit, subset to be used in VLM for tests with pmol/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.UNIT_LB_umol/L">Unit, subset to be used in VLM for tests with umol/L as the unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VSTEST">Vital Signs Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VSTESTCD">Vital Signs Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_BP">Units for Vital Signs Results, subset for Blood Pressure</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_BP_STD">Units for Vital Signs Results, subset for Blood Pressure Std</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_HEIGHT">Units for Vital Signs Results, subset for Height</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_HEIGHT_STD">Units for Vital Signs Results, subset for Height Std</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_PULSE">Units for Vital Signs Results, subset for Pulse</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_PULSE_STD">Units for Vital Signs Results, subset for Pulse Std</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_TEMP">Units for Vital Signs Results, subset for Temperature</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_TEMP_STD">Units for Vital Signs Results, subset for Temperature Std</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_WT">Units for Vital Signs Results, subset for Weight</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.VS_UNIT_WT_STD">Units for Vital Signs Results, subset for Weight Std</a></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#externaldictionary">External Dictionaries</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ISO21090">Null Flavors</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ISO3166">Country Codes</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.MEDDRA">Adverse Events Dictionary</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SNOMED">Trial Summary Medical Dictionary</a></li></ul></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#compmethod">Methods</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.AEENTPT">Algorithm to derive AEENTPT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.CMENTPT">Algorithm to derive CMENTPT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.DAYCALC">Algorithm to derive DAYCALC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.DISEQ">Algorithm to derive DISEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.DTHFL">Algorithm to derive DTHFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.EPOCH">Algorithm to derive EPOCH</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.EXDOSE">Algorithm to derive EXDOSE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.FTSTRESN">Algorithm to derive FTSTRESN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.IEORRES">Algorithm to derive IEORRES</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.LBSTRESC">Algorithm to derive LBSTRESC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.LOBXFL">Algorithm to derive LOBXFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.QSSTRESC_PH">Algorithm to derive QSSTRESC_PH</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.QSSTRESC_PH_10_11">Algorithm to derive QSSTRESC_PH_10_11</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.QSSTRESC_SL">Algorithm to derive QSSTRESC_SL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.QSSTRESN">Algorithm to derive QSSTRESN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.RFENDTC">Algorithm to derive RFENDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.RFPENDTC">Algorithm to derive RFPENDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.RFSTDTC">Algorithm to derive RFSTDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.RFXENDTC">Algorithm to derive RFXENDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.RFXSTDTC">Algorithm to derive RFXSTDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.RSSTRESC">Algorithm to derive RSSTRESC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.SEENDTC">Algorithm to derive SEENDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.SEQ">Algorithm to derive SEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.SESTDTC">Algorithm to derive SESTDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.STRESN">Algorithm to derive STRESN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.SVENDTC">Algorithm to derive SVENDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.SVSTDTC">Algorithm to derive SVSTDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.TSSEQ">Algorithm to derive TSSEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.VSSTRESC">Algorithm to derive VSSTRESC</a></li></ul></li></ul><div class="buttons"><div class="button"><button type="button" onclick="expand_all_vlm();">Expand all VLM</button></div><div class="button"><button type="button" onclick="collapse_all_vlm();">Collapse all VLM</button></div></div></div><div id="main"><div class="docinfo"><p class="documentinfo">Date/Time of Define-XML document generation: 2021-01-24T16:59:33</p><p class="documentinfo">Define-XML version: 2.1.0</p><p class="documentinfo">Define-XML Context: Submission</p><p class="stylesheetinfo">Stylesheet version: 2019-02-11</p></div><div class="study-metadata"><dl class="study-metadata"><dt>Study Name</dt><dd>CDISCPILOT01</dd><dt>Study Description</dt><dd>Study Data Tabulation Model Metadata Submission Guidelines Sample Study</dd><dt>Protocol Name</dt><dd>CDISCPILOT01</dd><dt>Metadata Name</dt><dd>Data Definitions for MSGv2.0 SDTM datasets.</dd><dt>Metadata Description</dt><dd>This metadata version contains only a subset of SDTM domains available in the SDTMIG 3.3. The data contained do not represent the data which would appear together in an actual regulatory submission.</dd></dl><div class="description"><p class="linebreakcell">Standard's Conformance Notes: 1) The SDTM v1.7/SDTMIG v3.3 datasets were evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC SDTM v1.7/SDTMIG v3.3 conformance rules were recently published, but not available by any validation tools to validate. 2) The Define-XML document was evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC Define-XML v2.1 conformance rules were not published, nor available by any validation tools to validate. Please ensure that any official regulatory submission of an Define-XML v2.1 document and accompanying data is done in accordance to the respective regulatory health authorities requirements/guidance.</p></div></div><h1 class="invisible">Standards for Study CDISCPILOT01</h1><div class="containerbox"><table id="Standards_Table" summary="Standards"><caption class="header">Standards for Study CDISCPILOT01</caption><tr class="header"><th scope="col">Standard</th><th scope="col">Type</th><th scope="col">Status</th><th scope="col">Documentation</th></tr><tr class="tablerowodd" id="STD.STD.1"><td>STDTMIG 3.3</td><td>IG</td><td>Final</td><td><p class="linebreakcell">Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.3</p></td></tr><tr class="tableroweven" id="STD.STD.2_1"><td>SDTMIG-MD 1.1</td><td>IG</td><td>Final</td><td><p class="linebreakcell">Study Data Tabulation Model Implementation Guide for Medical Devices Version 1.0</p></td></tr><tr class="tablerowodd" id="STD.STD.4"><td>CDISC/NCI DEFINE-XML 2020-12-18</td><td>CT</td><td>Final</td><td><p class="linebreakcell">This was the CDISC CT Package associated to the CDISC Define-XML Specification Version 2.1 when this sample submission was completed.</p></td></tr><tr class="tableroweven" id="STD.STD.3"><td>CDISC/NCI SDTM 2020-12-18</td><td>CT</td><td>Final</td><td><p class="linebreakcell">This was the latest release of CDISC CT available when this sample submission was completed.</p></td></tr></table></div><br><a id="datasets"></a><h1 class="invisible">Datasets</h1><div class="containerbox"><table summary="Data Definition Tables"><caption class="header">Datasets</caption><tr class="header"><th scope="col">Dataset</th><th scope="col">Description</th><th scope="col">Class
            
            </th><th scope="col">Structure</th><th scope="col">Purpose</th><th scope="col">Keys</th><th scope="col">Documentation</th><th scope="col">Location</th></tr><tr class="tablerowodd" id="IG.TA"><td><a href="#IG.IG.TA">TA</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Trial Arms</td><td>TRIAL DESIGN</td><td>One record per planned Element per Arm</td><td>Tabulation</td><td>STUDYID, ARMCD, TAETORD</td><td></td><td><a class="external" href="ta.xpt">ta.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.TE"><td><a href="#IG.IG.TE">TE</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Trial Elements</td><td>TRIAL DESIGN</td><td>One record per planned Element</td><td>Tabulation</td><td>STUDYID, ETCD</td><td></td><td><a class="external" href="te.xpt">te.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.TI"><td><a href="#IG.IG.TI">TI</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Trial Inclusion/Exclusion Criteria</td><td>TRIAL DESIGN</td><td>One record per I/E criterion</td><td>Tabulation</td><td>STUDYID, IETESTCD, TIVERS</td><td></td><td><a class="external" href="ti.xpt">ti.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.TS"><td><a href="#IG.IG.TS">TS</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Trial Summary</td><td>TRIAL DESIGN</td><td>One record per trial summary parameter value</td><td>Tabulation</td><td>STUDYID, TSPARMCD, TSVAL, TSSEQ</td><td></td><td><a class="external" href="ts.xpt">ts.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.TV"><td><a href="#IG.IG.TV">TV</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Trial Visits</td><td>TRIAL DESIGN</td><td>One record per planned Visit per Arm</td><td>Tabulation</td><td>STUDYID, VISITNUM, ARMCD</td><td></td><td><a class="external" href="tv.xpt">tv.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.DM"><td><a href="#IG.IG.DM">DM</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Demographics</td><td>SPECIAL PURPOSE</td><td>One record per subject</td><td>Tabulation</td><td>STUDYID, USUBJID</td><td></td><td><a class="external" href="dm.xpt">dm.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.SE"><td><a href="#IG.IG.SE">SE</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Subject Elements</td><td>SPECIAL PURPOSE</td><td>One record per actual Element per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, SESTDTC, ETCD</td><td></td><td><a class="external" href="se.xpt">se.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.SV"><td><a href="#IG.IG.SV">SV</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Subject Visits</td><td>SPECIAL PURPOSE</td><td>One record per actual visit per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, SVSTDTC, VISITNUM</td><td></td><td><a class="external" href="sv.xpt">sv.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.CM"><td><a href="#IG.IG.CM">CM</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Concomitant Medications</td><td>INTERVENTIONS</td><td>One record per recorded medication occurrence or constant-dosing interval per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, CMSTDTC, CMTRT</td><td></td><td><a class="external" href="cm.xpt">cm.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.EC"><td><a href="#IG.IG.EC">EC</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Exposure as Collected</td><td>INTERVENTIONS</td><td>One record per constant-dosing interval per mood per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, ECTRT, ECSTDTC</td><td></td><td><a class="external" href="ec.xpt">ec.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.EX"><td><a href="#IG.IG.EX">EX</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Exposure</td><td>INTERVENTIONS</td><td>One record per constant dosing interval per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, EXTRT, EXSTDTC</td><td></td><td><a class="external" href="ex.xpt">ex.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.AE"><td><a href="#IG.IG.AE">AE</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Adverse Events</td><td>EVENTS</td><td>One record per adverse event per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, AEDECOD, AESTDTC, AELNKID</td><td></td><td><a class="external" href="ae.xpt">ae.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.DS"><td><a href="#IG.IG.DS">DS</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Disposition</td><td>EVENTS</td><td>One record per disposition status or protocol milestone per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, DSSTDTC, DSCAT, DSSCAT, DSDECOD</td><td></td><td><a class="external" href="ds.xpt">ds.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.MH"><td><a href="#IG.IG.MH">MH</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Medical History</td><td>EVENTS</td><td>One record per medical history event per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, MHTERM, MHSTDTC</td><td></td><td><a class="external" href="mh.xpt">mh.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.DD"><td><a href="#IG.IG.DD">DD</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Death Details</td><td>FINDINGS</td><td>One record per death detail per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, DDTESTCD</td><td></td><td><a class="external" href="dd.xpt">dd.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.FT"><td><a href="#IG.IG.FT">FT</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Functional Tests</td><td>FINDINGS</td><td>One record per functional test finding per timepoint per visit per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, FTTESTCD, FTREPNUM, VISITNUM</td><td></td><td><a class="external" href="ft.xpt">ft.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.IE"><td><a href="#IG.IG.IE">IE</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Inclusion/Exclusion Criteria Not Met</td><td>FINDINGS</td><td>One record per inclusion/exclusion criterion not met per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, IETESTCD</td><td></td><td><a class="external" href="ie.xpt">ie.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.LB"><td><a href="#IG.IG.LB">LB</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Laboratory Test Results</td><td>FINDINGS</td><td>One record per analyte per visit per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, LBCAT, LBTESTCD, LBDTC, VISITNUM</td><td></td><td><a class="external" href="lb.xpt">lb.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.NV"><td><a href="#IG.IG.NV">NV</a><span class="standard-refeference">[STDTMIG 3.3]</span><span class="nodata">[No Data]</span></td><td>Nervous System Findings</td><td>FINDINGS</td><td>One record per finding per visit per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, NVTESTCD, VISITNUM</td><td><p class="linebreakcell">Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such was not submitted.</p></td><td></td></tr><tr class="tableroweven" id="IG.OE"><td><a href="#IG.IG.OE">OE</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Ophthalmic Examinations</td><td>FINDINGS</td><td>One record per ophthalmic finding per visit per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, OETESTCD, OELOC, OELAT, VISITNUM</td><td></td><td><a class="external" href="oe.xpt">oe.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.QSPH"><td><a href="#IG.IG.QSPH">QSPH</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Questionnaires (PHQ-9) (Questionnaires)</td><td>FINDINGS</td><td>One record per questionnaire finding per visit per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, QSTESTCD, VISITNUM</td><td><p class="linebreakcell">QSPH contains the PATIENT HEALTH QUESTIONNAIRE-9 (PHQ-9) questionnaire data.</p></td><td><a class="external" href="qsph.xpt">qsph.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.QSSL"><td><a href="#IG.IG.QSSL">QSSL</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Questionnaires (SQLS) (Questionnaires)</td><td>FINDINGS</td><td>One record per questionnaire finding per visit per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, QSTESTCD, VISITNUM</td><td><p class="linebreakcell">QSSL contains the SATISFACTION WITH LIFE SURVEY (SWLS) questionnaire data.</p></td><td><a class="external" href="qssl.xpt">qssl.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.RS"><td><a href="#IG.IG.RS">RS</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Disease Response and Clin Classification</td><td>FINDINGS</td><td>One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator</td><td>Tabulation</td><td>STUDYID, USUBJID, RSTESTCD, VISITNUM</td><td></td><td><a class="external" href="rs.xpt">rs.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.VS"><td><a href="#IG.IG.VS">VS</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Vital Signs</td><td>FINDINGS</td><td>One record per vital sign measurement per visit per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, VSTESTCD, VSPOS, VISITNUM, VSREPNUM</td><td></td><td><a class="external" href="vs.xpt">vs.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.FA"><td><a href="#IG.IG.FA">FA</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Findings About Events or Interventions</td><td>FINDINGS ABOUT</td><td>One record per finding per object per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, FATESTCD, FALNKGRP, FAOBJ, FADTC</td><td><p class="linebreakcell">The FA domain contains Findings About Injection Site Reaction Adverse Events</p></td><td><a class="external" href="fa.xpt">fa.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.RELREC"><td><a href="#IG.IG.RELREC">RELREC</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Related Records</td><td>RELATIONSHIP</td><td>One record per related record, group of records or dataset</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID</td><td></td><td><a class="external" href="relrec.xpt">relrec.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.SUPPDM"><td><a href="#IG.IG.SUPPDM">SUPPDM</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Supplemental Qualifiers for DM (Demographics)</td><td>RELATIONSHIP</td><td>One record per IDVAR, IDVARVAL, and QNAM value per subject</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td></td><td><a class="external" href="suppdm.xpt">suppdm.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.SUPPEC"><td><a href="#IG.IG.SUPPEC">SUPPEC</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Supplemental Qualifiers for EC (Exposure as Collected)</td><td>RELATIONSHIP</td><td>One record per IDVAR, IDVARVAL, and QNAM value per subject</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td></td><td><a class="external" href="suppec.xpt">suppec.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.SUPPNV"><td><a href="#IG.IG.SUPPNV">SUPPNV</a><span class="standard-refeference">[STDTMIG 3.3]</span><span class="nodata">[No Data]</span></td><td>Supplemental Qualifiers for NV (Nervous System Findings)</td><td>RELATIONSHIP</td><td>One record per IDVAR, IDVARVAL, and QNAM value per subject</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td><p class="linebreakcell">Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such SUPPNV was not submitted.</p></td><td></td></tr><tr class="tableroweven" id="IG.SUPPOE"><td><a href="#IG.IG.SUPPOE">SUPPOE</a><span class="standard-refeference">[STDTMIG 3.3]</span><span class="nodata">[No Data]</span></td><td>Supplemental Qualifiers for OE (Ophthalmic Examinations)</td><td>RELATIONSHIP</td><td>One record per IDVAR, IDVARVAL, and QNAM value per subject</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td><p class="linebreakcell">No subjects within the trial had an ophthalmic examination of clinical significance to report. Therefore, no data exists for the SUPPOE dataset and as such was not submitted.</p></td><td></td></tr><tr class="tablerowodd" id="IG.DI"><td><a href="#IG.IG.DI">DI</a><span class="standard-refeference">[STDTMIG 3.3]</span></td><td>Device Identifiers</td><td>STUDY REFERENCE</td><td>One record per device identifier per device</td><td>Tabulation</td><td>STUDYID, SPDEVID, DIPARMCD</td><td></td><td><a class="external" href="di.xpt">di.xpt</a><span class="external-link-gif"></span> </td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TA"></a><div class="containerbox"><h1 class="invisible">Trial Arms (TA) </h1><table summary="ItemGroup IG.IG.TA"><caption><span>TA (Trial Arms) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ta.xpt">ta.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_TA">SDTM Domain Abbreviation, subset used for Trial Arms</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"TA" = "Trial Arms"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.ARMCD"></a>ARMCD</td><td>Planned Arm Code</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMCD">Arm Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"ZAN_LOW" = "Zanomaline Low Dose (54 mg)"</li><li class="codelist-item">•&nbsp;"ZAN_HIGH" = "Zanomaline High Dose (81 mg)"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.ARM"></a>ARM</td><td>Description of Planned Arm</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">28</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Zanomaline Low Dose (54 mg)"</li><li class="codelist-item">•&nbsp;"Zanomaline High Dose (81 mg)"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.TAETORD"></a>TAETORD</td><td>Planned Order of Element within Arm</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.ETCD"></a>ETCD</td><td>Element Code</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.ETCD">Element Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"HIGH" = "Zanomaline 81 mg"</li><li class="codelist-item">•&nbsp;"LOW" = "Zanomaline 54 mg"</li><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"SCREEN" = "Screening"</li><li class="codelist-item">•&nbsp;"TITRATE" = "Zanomaline 54 mg Titration"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.ELEMENT"></a>ELEMENT</td><td>Description of Element</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">26</td><td><span class="linebreakcell"><a href="#CL.CL.ELEMENT">Element</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Screening"</li><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Zanomaline 54 mg"</li><li class="codelist-item">•&nbsp;"Zanomaline 54 mg Titration"</li><li class="codelist-item">•&nbsp;"Zanomaline 81 mg"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.TABRANCH"></a>TABRANCH</td><td>Branch</td><td class="datatype">text</td><td class="role">Rule</td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.TATRANS"></a>TATRANS</td><td>Transition Rule</td><td class="datatype">text</td><td class="role">Rule</td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TE"></a><div class="containerbox"><h1 class="invisible">Trial Elements (TE) </h1><table summary="ItemGroup IG.IG.TE"><caption><span>TE (Trial Elements) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="te.xpt">te.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TE.IT.TE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TE.IT.TE.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_TE">SDTM Domain Abbreviation, subset used for Trial Elements</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"TE" = "Trial Elements"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TE.IT.TE.ETCD"></a>ETCD</td><td>Element Code</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.ETCD">Element Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"HIGH" = "Zanomaline 81 mg"</li><li class="codelist-item">•&nbsp;"LOW" = "Zanomaline 54 mg"</li><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"SCREEN" = "Screening"</li><li class="codelist-item">•&nbsp;"TITRATE" = "Zanomaline 54 mg Titration"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TE.IT.TE.ELEMENT"></a>ELEMENT</td><td>Description of Element</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">26</td><td><span class="linebreakcell"><a href="#CL.CL.ELEMENT">Element</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Screening"</li><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Zanomaline 54 mg"</li><li class="codelist-item">•&nbsp;"Zanomaline 54 mg Titration"</li><li class="codelist-item">•&nbsp;"Zanomaline 81 mg"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TE.IT.TE.TESTRL"></a>TESTRL</td><td>Rule for Start of Element</td><td class="datatype">text</td><td class="role">Rule</td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TE.IT.TE.TEENRL"></a>TEENRL</td><td>Rule for End of Element</td><td class="datatype">text</td><td class="role">Rule</td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TI"></a><div class="containerbox"><h1 class="invisible">Trial Inclusion/Exclusion Criteria (TI) </h1><table summary="ItemGroup IG.IG.TI"><caption><span>TI (Trial Inclusion/Exclusion Criteria) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ti.xpt">ti.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TI.IT.TI.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TI.IT.TI.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_TI">SDTM Domain Abbreviation, subset used for Trial Inclusion/Exclusion Criteria</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"TI" = "Trial Inclusion"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TI.IT.TI.IETESTCD"></a>IETESTCD</td><td>Incl/Excl Criterion Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td><a href="#CL.CL.IETESTCD">Incl/Excl Criterion Short Name</a><p class="linebreakcell">
                  [33 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TI.IT.TI.IETEST"></a>IETEST</td><td>Inclusion/Exclusion Criterion</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">196</td><td><a href="#CL.CL.IETEST">Inclusion/Exclusion Criterion</a><p class="linebreakcell">
                  [33 Terms]
                </p></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TI.IT.TI.IECAT"></a>IECAT</td><td>Inclusion/Exclusion Category</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.IECAT">Category for Inclusion/Exclusion</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"EXCLUSION" = "Exclusion"</li><li class="codelist-item">•&nbsp;"INCLUSION" = "Inclusion"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TI.IT.TI.TIVERS"></a>TIVERS</td><td>Protocol Criteria Versions</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TS"></a><div class="containerbox"><h1 class="invisible">Trial Summary (TS) </h1><table summary="ItemGroup IG.IG.TS"><caption><span>TS (Trial Summary) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ts.xpt">ts.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TS.IT.TS.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_TS">SDTM Domain Abbreviation, subset used for Trial Summary</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"TS" = "Trial Summary"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TS.IT.TS.TSSEQ"></a>TSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within each TSPARM, restarting at 1 for per TSPARM, applied to sorted data.</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.TSGRPID"></a>TSGRPID</td><td></td><td>Group ID</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TS.IT.TS.TSPARMCD"></a>TSPARMCD</td><td></td><td>Trial Summary Parameter Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><a href="#CL.CL.TSPARMCD">Trial Summary Parameter Test Code</a><p class="linebreakcell">
                  [44 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.TSPARM"></a>TSPARM</td><td></td><td>Trial Summary Parameter</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">40</td><td><a href="#CL.CL.TSPARM">Trial Summary Parameter Test Name</a><p class="linebreakcell">
                  [44 Terms]
                </p></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td>TSVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.TS.IT.TS.TSVAL">VLM</a></span></td><td></td><td>Parameter Value</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> IN (<br><span class="linebreakcell">"ADAPT" (Adaptive Study Design Indicator), </span><br><span class="linebreakcell">"ADDON" (Test Product Added to Existing Treatment), </span><br><span class="linebreakcell">"HLTSUBJI" (Healthy Subject Indicator), </span><br><span class="linebreakcell">"RANDOM" (Randomization)</span><br>) </td><td>Trial Summary Yes No Responses</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> IN (<br><span class="linebreakcell">"ACTSUB" (Actual Subject Number), </span><br><span class="linebreakcell">"AGEMAX" (Planned Maximum Age of Subjects), </span><br><span class="linebreakcell">"AGEMIN" (Planned Minimum Age of Subjects), </span><br><span class="linebreakcell">"DOSE" (Dose), </span><br><span class="linebreakcell">"NARMS" (Planned Number of Arms), </span><br><span class="linebreakcell">"PLANSUB" (Planned Subject Number)</span><br>) </td><td>Planned Maximum Age of Subjects</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> IN (<br><span class="linebreakcell">"DCUTDTC" (Data Cutoff Date), </span><br><span class="linebreakcell">"SENDTC" (Clinical Study End Date), </span><br><span class="linebreakcell">"SSTDTC" (Study Start Date)</span><br>) </td><td>Trial Summary Date Responses</td><td class="datatype">date</td><td class="role"></td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "DOSFRM" (Pharmaceutical Dosage Form)</td><td>Dose Form</td><td class="datatype">text</td><td class="role"></td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.FRM_ECEX">Dose Form, subset used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"INJECTION" = "Injectable Dosage Form"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "DOSFRQ" (Dose Frequency)</td><td>Dosing Frequency</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.FREQ_ECEX">Frequency, subset used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"QD" = "Daily"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "DOSU" (Dosage Form Unit)</td><td>Dose Units</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_EX">Unit, subset to be used for EXDOSU</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg" = "Milligram"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "FCNTRY" (Planned Country of Investigational Site)</td><td>Planned Country of Investigational Sites</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><a href="#CL.CL.ISO3166">Country Codes</a><p class="linebreakcell">ISO 3166-1 Alpha-3 2013-11-15</p></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "INDIC" (Trial Indication)</td><td>Trial Disease/Condition Indication</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><a href="#CL.CL.SNOMED">Trial Summary Medical Dictionary</a><p class="linebreakcell">SNOMED 2019-09-01</p></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "INTMODEL" (Intervention Model)</td><td>Intervention Model</td><td class="datatype">text</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.INTMODEL">Intervention Model Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PARALLEL" = "Parallel"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "INTTYPE" (Intervention Type)</td><td>Intervention Type</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.INTTYPE">Intervention Type Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DRUG" = "Drug"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TS_DURATION"</td><td>Trial Length</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "OBJPRIM" (Trial Primary Objective)</td><td>Trial Primary Objective</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "OBJSEC" (Trial Secondary Objective)</td><td>Trial Secondary Objective</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "OUTMSPRI" (Primary Outcome Measure)</td><td>Primary Outcome Measure</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "PCLAS" (Pharmacological Class of Investigational Therapy)</td><td>Pharmacologic Class</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TS_FLOAT"</td><td>Randomization Quotient</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "REGID" (Clinical Trial Registry Identifier)</td><td>Registry Identifier</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "ROUTE" (Route of Administration)</td><td>Route of Administration</td><td class="datatype">text</td><td class="role"></td><td class="number">12</td><td><span class="linebreakcell"><a href="#CL.CL.ROUTE_ECEX">Route of Administration, subset to be used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SUBCUTANEOUS" = "Subcutaneous Route of Administration"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> IN (<br><span class="linebreakcell">"SDTIGVER" (Study Data Tabulation Model Implementation Guide Version), </span><br><span class="linebreakcell">"SDTMVER" (Study Data Tabulation Model Version)</span><br>) </td><td>SDTM IG Version</td><td class="datatype">float</td><td class="role"></td><td class="number">2</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "SEXPOP" (Sex of Study Group)</td><td>Sex of Participants</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex Male Female</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "SPONSOR" (Clinical Study Sponsor)</td><td>Clinical Study Sponsor</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "STOPRULE" (Study Stop Rule)</td><td>Study Stop Rules</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "STYPE" (Study Type)</td><td>Study Type</td><td class="datatype">text</td><td class="role"></td><td class="number">14</td><td><span class="linebreakcell"><a href="#CL.CL.STYPE">Study Type Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"INTERVENTIONAL" = "Interventional"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TBLIND" (Trial Blinding Schema)</td><td>Trial Blinding Schema</td><td class="datatype">text</td><td class="role"></td><td class="number">12</td><td><span class="linebreakcell"><a href="#CL.CL.TBLIND">Trial Blinding Schema Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DOUBLE BLIND" = "Double Blind"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TCNTRL" (Control Type)</td><td>Control Type</td><td class="datatype">text</td><td class="role"></td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.TCNTRL">Control Type Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TDIGRP" (Diagnosis Group)</td><td>Diagnosis Group</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><a href="#CL.CL.SNOMED">Trial Summary Medical Dictionary</a><p class="linebreakcell">SNOMED 2019-09-01</p></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TINDTP" (Clinical Study by Intent)</td><td>Trial Intent Type</td><td class="datatype">text</td><td class="role"></td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.TINDTP">Trial Intent Type Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TITLE" (Trial Title)</td><td>Trial Title</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TPHASE" (Trial Phase)</td><td>Trial Phase Classification</td><td class="datatype">text</td><td class="role"></td><td class="number">14</td><td><span class="linebreakcell"><a href="#CL.CL.TPHASE">Trial Phase Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PHASE II TRIAL" = "Phase II Trial"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TRT" (Protocol Agent)</td><td>Investigational Therapy or Treatment</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TTYPE" (Trial Type)</td><td>Trial Type</td><td class="datatype">text</td><td class="role"></td><td class="number">15</td><td><span class="linebreakcell"><a href="#CL.CL.TTYPE">Trial Type Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"EFFICACY" = "Efficacy"</li><li class="codelist-item">•&nbsp;"PHARMACOKINETIC" = "Pharmacokinetic"</li><li class="codelist-item">•&nbsp;"SAFETY" = "Safety"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.TSVALNF"></a>TSVALNF</td><td></td><td>Parameter Null Flavor</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">4</td><td><a href="#CL.CL.ISO21090">Null Flavors</a><p class="linebreakcell">ISO 21090 NullFlavor 2017</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TS.IT.TS.TSVALCD"></a>TSVALCD</td><td></td><td>Parameter Value Code</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.TSVCDREF"></a>TSVCDREF</td><td></td><td>Name of the Reference Terminology</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TS.IT.TS.TSVCDVER"></a>TSVCDVER</td><td></td><td>Version of the Reference Terminology</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TV"></a><div class="containerbox"><h1 class="invisible">Trial Visits (TV) </h1><table summary="ItemGroup IG.IG.TV"><caption><span>TV (Trial Visits) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="tv.xpt">tv.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TV.IT.TV.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TV.IT.TV.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_TV">SDTM Domain Abbreviation, subset used for Trial Visits</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"TV" = "Trial Visits"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TV.IT.TV.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="role">Topic</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TV.IT.TV.VISIT"></a>VISIT</td><td>Visit Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TV.IT.TV.ARMCD"></a>ARMCD</td><td>Planned Arm Code</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMCD">Arm Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"ZAN_LOW" = "Zanomaline Low Dose (54 mg)"</li><li class="codelist-item">•&nbsp;"ZAN_HIGH" = "Zanomaline High Dose (81 mg)"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.TV.IT.TV.TVSTRL"></a>TVSTRL</td><td>Visit Start Rule</td><td class="datatype">text</td><td class="role">Rule</td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.TV.IT.TV.TVENRL"></a>TVENRL</td><td>Visit End Rule</td><td class="datatype">text</td><td class="role">Rule</td><td class="number">200</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.DM"></a><div class="containerbox"><h1 class="invisible">Demographics (DM) </h1><table summary="ItemGroup IG.IG.DM"><caption><span>DM (Demographics) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="dm.xpt">dm.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPDM">SUPPDM</a> (Supplemental Qualifiers for DM)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_DM">SDTM Domain Abbreviation, subset used for Demographics</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DM" = "Demographics"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.SUBJID"></a>SUBJID</td><td></td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">4</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.RFSTDTC"></a>RFSTDTC</td><td></td><td>Subject Reference Start Date/Time</td><td class="datatype">date</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The first date/time of study drug. Null for screen failures.</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.RFENDTC"></a>RFENDTC</td><td></td><td>Subject Reference End Date/Time</td><td class="datatype">date</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The Date of Study Completion or Early Termination. Null for screen failures.</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.RFXSTDTC"></a>RFXSTDTC</td><td></td><td>Date/Time of First Study Treatment</td><td class="datatype">date</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The first date/time of study drug administration. Null for subjects with no treatment data.</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.RFXENDTC"></a>RFXENDTC</td><td></td><td>Date/Time of Last Study Treatment</td><td class="datatype">date</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The last date/time of study drug administration. Null for subjects with no treatment data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.RFICDTC"></a>RFICDTC</td><td></td><td>Date/Time of Informed Consent</td><td class="datatype">date</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.RFPENDTC"></a>RFPENDTC</td><td></td><td>Date/Time of End of Participation</td><td class="datatype">date</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The latest date of assessment for the subject as determined by the End of Study Form, any scheduled assessments, Adverse Events, or Concomitant Medications.</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.DTHDTC"></a>DTHDTC</td><td></td><td>Date/Time of Death</td><td class="datatype">date</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=26">26</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.DTHFL"></a>DTHFL</td><td></td><td>Subject Death Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If DTHDTC is populated then DTHFL='Y'</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.SITEID"></a>SITEID</td><td></td><td>Study Site Identifier</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">3</td><td><a href="#CL.CL.SITEID">Site Identifier</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.BRTHDTC"></a>BRTHDTC</td><td></td><td>Date/Time of Birth</td><td class="datatype">date</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="role">Record Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.AGEU"></a>AGEU</td><td></td><td>Age Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEU_YEARS">Age Unit in Years</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"YEARS" = "Years"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex Male Female</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td>RACE<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.DM.IT.DM.RACE">VLM</a></span></td><td></td><td>Race</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">41</td><td></td><td></td></tr><tr class="vlm tableroweven IG.DM.IT.DM.RACE"><td></td><td><a href="#IG.DM.IT.DM.RACE" title="Race">RACE</a> ≠ "MULTIPLE"</td><td>Race</td><td class="datatype">text</td><td class="role"></td><td class="number">41</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native"</li><li class="codelist-item">•&nbsp;"ASIAN" = "Asian"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN" = "Black Or African American"</li><li class="codelist-item">•&nbsp;"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander"</li><li class="codelist-item">•&nbsp;"WHITE" = "White"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.DM.IT.DM.RACE"><td></td><td><a href="#IG.DM.IT.DM.RACE" title="Race">RACE</a> = "MULTIPLE"</td><td>Race</td><td class="datatype">text</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEMULT">Race Multiple Selections</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"MULTIPLE" = "Multiple"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.ETHNIC"></a>ETHNIC</td><td></td><td>Ethnicity</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">22</td><td><span class="linebreakcell"><a href="#CL.CL.ETHNIC">Ethnic Group Hispanic</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"HISPANIC OR LATINO" = "Hispanic or Latino"</li><li class="codelist-item">•&nbsp;"NOT HISPANIC OR LATINO" = "Not Hispanic or Latino"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.ARMCD"></a>ARMCD</td><td></td><td>Planned Arm Code</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMCD">Arm Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"ZAN_LOW" = "Zanomaline Low Dose (54 mg)"</li><li class="codelist-item">•&nbsp;"ZAN_HIGH" = "Zanomaline High Dose (81 mg)"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.ARM"></a>ARM</td><td></td><td>Description of Planned Arm</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">28</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Zanomaline Low Dose (54 mg)"</li><li class="codelist-item">•&nbsp;"Zanomaline High Dose (81 mg)"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.ACTARMCD"></a>ACTARMCD</td><td></td><td>Actual Arm Code</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMCD">Arm Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"ZAN_LOW" = "Zanomaline Low Dose (54 mg)"</li><li class="codelist-item">•&nbsp;"ZAN_HIGH" = "Zanomaline High Dose (81 mg)"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.ACTARM"></a>ACTARM</td><td></td><td>Description of Actual Arm</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">28</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Zanomaline Low Dose (54 mg)"</li><li class="codelist-item">•&nbsp;"Zanomaline High Dose (81 mg)"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.ARMNRS"></a>ARMNRS</td><td></td><td>Reason Arm and/or Actual Arm is Null</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">14</td><td><span class="linebreakcell"><a href="#CL.CL.ARMNRS">Arm Null Reason</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREEN FAILURE" = "Trial Screen Failure"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.ACTARMUD"></a>ACTARMUD</td><td></td><td>Description of Unplanned Actual Arm</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.COUNTRY"></a>COUNTRY</td><td></td><td>Country</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">3</td><td><a href="#CL.CL.ISO3166">Country Codes</a><p class="linebreakcell">ISO 3166-1 Alpha-3 2013-11-15</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SE"></a><div class="containerbox"><h1 class="invisible">Subject Elements (SE) </h1><table summary="ItemGroup IG.IG.SE"><caption><span>SE (Subject Elements) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="se.xpt">se.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_SE">SDTM Domain Abbreviation, subset used for Subject Element</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SE" = "Subject Elements"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.SESEQ"></a>SESEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.ETCD"></a>ETCD</td><td>Element Code</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.ETCD">Element Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"HIGH" = "Zanomaline 81 mg"</li><li class="codelist-item">•&nbsp;"LOW" = "Zanomaline 54 mg"</li><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"SCREEN" = "Screening"</li><li class="codelist-item">•&nbsp;"TITRATE" = "Zanomaline 54 mg Titration"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.ELEMENT"></a>ELEMENT</td><td>Description of Element</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">26</td><td><span class="linebreakcell"><a href="#CL.CL.ELEMENT">Element</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Screening"</li><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Zanomaline 54 mg"</li><li class="codelist-item">•&nbsp;"Zanomaline 54 mg Titration"</li><li class="codelist-item">•&nbsp;"Zanomaline 81 mg"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.SESTDTC"></a>SESTDTC</td><td>Start Date/Time of Element</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">SESTDTC if set to the --DTC for that subject which exists in the data for the defined start of the Element, such as DSSTDTC when DSDECOD=INFORMED CONSENT OBTAINED for Screening Elements or min(EXSTDTC) for Dosing Elements.</div></td></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.SEENDTC"></a>SEENDTC</td><td>End Date/Time of Element</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">SEENDTC is set to the start of the next Element, or RFPENDTC for the last Element.</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.SESTDY"></a>SESTDY</td><td>Study Day of Start of Element</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.SEENDY"></a>SEENDY</td><td>Study Day of End of Element</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SV"></a><div class="containerbox"><h1 class="invisible">Subject Visits (SV) </h1><table summary="ItemGroup IG.IG.SV"><caption><span>SV (Subject Visits) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="sv.xpt">sv.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SV.IT.SV.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SV.IT.SV.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_SV">SDTM Domain Abbreviation, subset used for Subject Visits</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SV" = "Subject Visits"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SV.IT.SV.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SV.IT.SV.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="role">Topic</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SV.IT.SV.VISIT"></a>VISIT</td><td>Visit Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SV.IT.SV.SVSTDTC"></a>SVSTDTC</td><td>Start Date/Time of Visit</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For each scheduled visit, SVSTDTC = the first (min) date associated with a subject for that visit. For unplanned visits, SVSTDTC is the date of the visit.</div></td></tr><tr class="tablerowodd"><td><a id="IG.SV.IT.SV.SVENDTC"></a>SVENDTC</td><td>End Date/Time of Visit</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For each scheduled visit, SVENDTC = the last (max) date associated with a subject for that visit. For unplanned visits, SVENDTC is the date of the visit.</div></td></tr><tr class="tableroweven"><td><a id="IG.SV.IT.SV.SVSTDY"></a>SVSTDY</td><td>Study Day of Start of Visit</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tablerowodd"><td><a id="IG.SV.IT.SV.SVENDY"></a>SVENDY</td><td>Study Day of End of Visit</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tableroweven"><td><a id="IG.SV.IT.SV.SVUPDES"></a>SVUPDES</td><td>Description of Unplanned Visit</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.CM"></a><div class="containerbox"><h1 class="invisible">Concomitant Medications (CM) </h1><table summary="ItemGroup IG.IG.CM"><caption><span>CM (Concomitant Medications) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="cm.xpt">cm.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.CM.IT.CM.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_CM">SDTM Domain Abbreviation, subset used for Concomitant Meds</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CM" = "Concomitant/Prior Medications"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.CM.IT.CM.CMSEQ"></a>CMSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.CMTRT"></a>CMTRT</td><td>Reported Name of Drug, Med, or Therapy</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.CM.IT.CM.CMINDC"></a>CMINDC</td><td>Indication</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">If the CM is not taken for a 'Primary Study Condition' then CMINDC would be 'Prophylaxis or Non-therapeutic use'</p></td></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.CMDOSE"></a>CMDOSE</td><td>Dose per Administration</td><td class="datatype">float</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.CM.IT.CM.CMDOSU"></a>CMDOSU</td><td>Dose Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_CM">Unit, subset to be used for CMDOSU</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg" = "Milligram"</li><li class="codelist-item">•&nbsp;"ng" = "Nanogram"</li><li class="codelist-item">•&nbsp;"TABLET" = "Tablet"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.CMDOSFRQ"></a>CMDOSFRQ</td><td>Dosing Frequency per Interval</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">3</td><td><a href="#CL.CL.FREQ_CM">Frequency, subset used for CM</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.CM.IT.CM.CMROUTE"></a>CMROUTE</td><td>Route of Administration</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">24</td><td><a href="#CL.CL.ROUTE_CM">Route of Administration, subset to be used for CM</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.CM.IT.CM.CMSTDTC"></a>CMSTDTC</td><td>Start Date/Time of Medication</td><td class="datatype">partialDate</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.CMENDTC"></a>CMENDTC</td><td>End Date/Time of Medication</td><td class="datatype">partialDate</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.CM.IT.CM.CMSTDY"></a>CMSTDY</td><td>Study Day of Start of Medication</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.CMENDY"></a>CMENDY</td><td>Study Day of End of Medication</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tableroweven"><td><a id="IG.CM.IT.CM.CMENRTPT"></a>CMENRTPT</td><td>End Relative to Reference Time Point</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.ENRTPT_CM_AE">Relation to Reference Period, subset used for AE and CM.</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ONGOING" = "Ongoing"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=25">25</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.CM.IT.CM.CMENTPT"></a>CMENTPT</td><td>End Reference Time Point</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If CMENRTPT is populated, CMENTPT is DM.RFPENDTC for the subject.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.EC"></a><div class="containerbox"><h1 class="invisible">Exposure as Collected (EC) </h1><table summary="ItemGroup IG.IG.EC"><caption><span>EC (Exposure as Collected) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ec.xpt">ec.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPEC">SUPPEC</a> (Supplemental Qualifiers for EC)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_EC">SDTM Domain Abbreviation, subset used for Exposure as Collected</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"EC" = "Exposure as Collected"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.SPDEVID"></a>SPDEVID</td><td>Sponsor Device Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.ECSEQ"></a>ECSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.ECTRT"></a>ECTRT</td><td>Name of Treatment</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">10</td><td><span class="linebreakcell"><a href="#CL.CL.EXTRT">Study Treatment</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"ZANOMALINE" = "Zanomaline"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.ECPRESP"></a>ECPRESP</td><td>Pre-Specified</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.ECOCCUR"></a>ECOCCUR</td><td>Occurrence</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.ECDOSE"></a>ECDOSE</td><td>Dose</td><td class="datatype">integer</td><td class="role">Record Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.ECDOSU"></a>ECDOSU</td><td>Dose Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_ECDOSU">Unit, subset to be used for ECDOSU</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mL" = "Milliliter"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.ECDOSFRM"></a>ECDOSFRM</td><td>Dose Form</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.FRM_ECEX">Dose Form, subset used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"INJECTION" = "Injectable Dosage Form"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.ECDOSFRQ"></a>ECDOSFRQ</td><td>Dosing Frequency per Interval</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.FREQ_ECEX">Frequency, subset used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"QD" = "Daily"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.ECROUTE"></a>ECROUTE</td><td>Route of Administration</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">12</td><td><span class="linebreakcell"><a href="#CL.CL.ROUTE_ECEX">Route of Administration, subset to be used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SUBCUTANEOUS" = "Subcutaneous Route of Administration"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.ECLOT"></a>ECLOT</td><td>Lot Number</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.ECPSTRG"></a>ECPSTRG</td><td>Pharmaceutical Strength</td><td class="datatype">float</td><td class="role">Record Qualifier</td><td class="number">4</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.ECPSTRGU"></a>ECPSTRGU</td><td>Pharmaceutical Strength Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_ECPSTRGU">Unit, subset to be used for ECPSTRGU</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"g/L" = "Gram per Liter"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.ECSTDTC"></a>ECSTDTC</td><td>Start Date/Time of Treatment</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.ECENDTC"></a>ECENDTC</td><td>End Date/Time of Treatment</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.EC.IT.EC.ECSTDY"></a>ECSTDY</td><td>Study Day of Start of Treatment</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tablerowodd"><td><a id="IG.EC.IT.EC.ECENDY"></a>ECENDY</td><td>Study Day of End of Treatment</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.EX"></a><div class="containerbox"><h1 class="invisible">Exposure (EX) </h1><table summary="ItemGroup IG.IG.EX"><caption><span>EX (Exposure) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ex.xpt">ex.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_EX">SDTM Domain Abbreviation, subset used for Exposure</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"EX" = "Exposure"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.SPDEVID"></a>SPDEVID</td><td>Sponsor Device Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Predecessor: EC.SPDEVID</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXSEQ"></a>EXSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXTRT"></a>EXTRT</td><td>Name of Treatment</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">10</td><td><span class="linebreakcell"><a href="#CL.CL.EXTRT">Study Treatment</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PLACEBO" = "Placebo"</li><li class="codelist-item">•&nbsp;"ZANOMALINE" = "Zanomaline"</li></ul></td><td><div class="linebreakcell">Predecessor: ECTRT</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXDOSE"></a>EXDOSE</td><td>Dose</td><td class="datatype">integer</td><td class="role">Record Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EXDOSE = ECDOSE * ECPSTRG expressed in mg.</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXDOSU"></a>EXDOSU</td><td>Dose Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_EX">Unit, subset to be used for EXDOSU</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg" = "Milligram"</li></ul></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXDOSFRM"></a>EXDOSFRM</td><td>Dose Form</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.FRM_ECEX">Dose Form, subset used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"INJECTION" = "Injectable Dosage Form"</li></ul></td><td><div class="linebreakcell">Predecessor: ECDOSFRM</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXDOSFRQ"></a>EXDOSFRQ</td><td>Dosing Frequency per Interval</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.FREQ_ECEX">Frequency, subset used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"QD" = "Daily"</li></ul></td><td><div class="linebreakcell">Predecessor: ECDOSFRQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXROUTE"></a>EXROUTE</td><td>Route of Administration</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">12</td><td><span class="linebreakcell"><a href="#CL.CL.ROUTE_ECEX">Route of Administration, subset to be used for EC and EX</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SUBCUTANEOUS" = "Subcutaneous Route of Administration"</li></ul></td><td><div class="linebreakcell">Predecessor: ECROUTE</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXLOT"></a>EXLOT</td><td>Lot Number</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Predecessor: ECLOT</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Predecessor: EC.EPOCH</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXSTDTC"></a>EXSTDTC</td><td>Start Date/Time of Treatment</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Predecessor: ECSTDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXENDTC"></a>EXENDTC</td><td>End Date/Time of Treatment</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Predecessor: ECENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXSTDY"></a>EXSTDY</td><td>Study Day of Start of Treatment</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ECSTDY</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXENDY"></a>EXENDY</td><td>Study Day of End of Treatment</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ECENDY</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.AE"></a><div class="containerbox"><h1 class="invisible">Adverse Events (AE) </h1><table summary="ItemGroup IG.IG.AE"><caption><span>AE (Adverse Events) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ae.xpt">ae.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_AE">SDTM Domain Abbreviation, subset used for Adverse Events</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AE" = "Adverse Events"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESEQ"></a>AESEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AELNKID"></a>AELNKID</td><td></td><td>Link ID</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">50</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td>AETERM<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.AE.IT.AE.AETERM">VLM</a></span></td><td></td><td>Reported Term for the Adverse Event</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">200</td><td></td><td></td></tr><tr class="vlm tableroweven IG.AE.IT.AE.AETERM"><td></td><td><a href="#IG.AE.IT.AE.AETERM" title="Reported Term for the Adverse Event">AETERM</a> = "INJECTION SITE REACTION"</td><td>Reported Term for the Adverse Event</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">Even though the variable is 'Assigned' an annotation has been added to page 23 to clarify the assignment.</p></td></tr><tr class="vlm tableroweven IG.AE.IT.AE.AETERM"><td></td><td><a href="#IG.AE.IT.AE.AETERM" title="Reported Term for the Adverse Event">AETERM</a> ≠ "INJECTION SITE REACTION"</td><td>Reported Term for the Adverse Event</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AELLT"></a>AELLT<span class="nodata">[No Data]</span></td><td></td><td>Lowest Level Term</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AELLTCD"></a>AELLTCD<span class="nodata">[No Data]</span></td><td></td><td>Lowest Level Term Code</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEDECOD"></a>AEDECOD<span class="nodata">[No Data]</span></td><td></td><td>Dictionary-Derived Term</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required. Note CDISC Conformance Rule CG0014 would fire for this variable due to the decision not to populate coding variables.</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AEPTCD"></a>AEPTCD<span class="nodata">[No Data]</span></td><td></td><td>Preferred Term Code</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEHLT"></a>AEHLT<span class="nodata">[No Data]</span></td><td></td><td>High Level Term</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AEHLTCD"></a>AEHLTCD<span class="nodata">[No Data]</span></td><td></td><td>High Level Term Code</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEHLGT"></a>AEHLGT<span class="nodata">[No Data]</span></td><td></td><td>High Level Group Term</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AEHLGTCD"></a>AEHLGTCD<span class="nodata">[No Data]</span></td><td></td><td>High Level Group Term Code</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEBODSYS"></a>AEBODSYS<span class="nodata">[No Data]</span></td><td></td><td>Body System or Organ Class</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AEBDSYCD"></a>AEBDSYCD<span class="nodata">[No Data]</span></td><td></td><td>Body System or Organ Class Code</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AESOC"></a>AESOC<span class="nodata">[No Data]</span></td><td></td><td>Primary System Organ Class</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESOCCD"></a>AESOCCD<span class="nodata">[No Data]</span></td><td></td><td>Primary System Organ Class Code</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">1</td><td><a href="#CL.CL.MEDDRA">Adverse Events Dictionary</a><p class="linebreakcell">MedDRA 22.0</p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required.</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AESEV"></a>AESEV</td><td></td><td>Severity/Intensity</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AESEV">Severity/Intensity Scale for Adverse Events</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"MILD" = "Mild"</li><li class="codelist-item">•&nbsp;"MODERATE" = "Moderate"</li><li class="codelist-item">•&nbsp;"SEVERE" = "Severe"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESER"></a>AESER</td><td></td><td>Serious Event</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">Subject CDISC003 had an AE of Epistaxis on 2013-09-30 with AESER set to 'Y' without any of the individual serious qualifiers set to 'Y' also. The site was queried several times but the data were not updated. Note Conformance Rule CG0041 would fire for this subject.</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEACN"></a>AEACN</td><td></td><td>Action Taken with Study Treatment</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">16</td><td><a href="#CL.CL.ACN">Action Taken with Study Treatment</a><p class="linebreakcell">
                  [7 Terms]
                </p></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AEREL"></a>AEREL</td><td></td><td>Causality</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">16</td><td><span class="linebreakcell"><a href="#CL.CL.AEREL">Relationship</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"RELATED" = "Related"</li><li class="codelist-item">•&nbsp;"UNLIKELY RELATED" = "Unlikely Related"</li><li class="codelist-item">•&nbsp;"POSSIBLY RELATED" = "Possibly Related"</li><li class="codelist-item">•&nbsp;"NOT RELATED" = "Not Related"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEOUT"></a>AEOUT</td><td></td><td>Outcome of Adverse Event</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">32</td><td><a href="#CL.CL.OUT">Outcome of Event</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESCAN"></a>AESCAN</td><td></td><td>Involves Cancer</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AESCONG"></a>AESCONG</td><td></td><td>Congenital Anomaly or Birth Defect</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESDISAB"></a>AESDISAB</td><td></td><td>Persist or Signif Disability/Incapacity</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AESDTH"></a>AESDTH</td><td></td><td>Results in Death</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESHOSP"></a>AESHOSP</td><td></td><td>Requires or Prolongs Hospitalization</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AESLIFE"></a>AESLIFE</td><td></td><td>Is Life Threatening</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESOD"></a>AESOD</td><td></td><td>Occurred with Overdose</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESTDTC"></a>AESTDTC</td><td></td><td>Start Date/Time of Adverse Event</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEENDTC"></a>AEENDTC</td><td></td><td>End Date/Time of Adverse Event</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AESTDY"></a>AESTDY</td><td></td><td>Study Day of Start of Adverse Event</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEENDY"></a>AEENDY</td><td></td><td>Study Day of End of Adverse Event</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tableroweven"><td><a id="IG.AE.IT.AE.AEENRTPT"></a>AEENRTPT</td><td></td><td>End Relative to Reference Time Point</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.ENRTPT_CM_AE">Relation to Reference Period, subset used for AE and CM.</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ONGOING" = "Ongoing"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=22">22</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.AE.IT.AE.AEENTPT"></a>AEENTPT</td><td></td><td>End Reference Time Point</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If AEENRTPT is populated, AEENTPT is DM.RFPENDTC for the subject.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.DS"></a><div class="containerbox"><h1 class="invisible">Disposition (DS) </h1><table summary="ItemGroup IG.IG.DS"><caption><span>DS (Disposition) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ds.xpt">ds.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_DS">SDTM Domain Abbreviation, subset used for Disposition</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DS" = "Disposition"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.DSSEQ"></a>DSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.DSLNKID"></a>DSLNKID</td><td></td><td>Link ID</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">50</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=27">27</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=28">28</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td>DSTERM<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.DS.IT.DS.DSTERM">VLM</a></span></td><td></td><td>Reported Term for the Disposition Event</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">200</td><td></td><td></td></tr><tr class="vlm tableroweven IG.DS.IT.DS.DSTERM"><td></td><td><a href="#IG.DS.IT.DS.DSSCAT" title="Subcategory for Disposition Event">DSSCAT</a> ≠ ""</td><td>Reported Term for the Disposition Event</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=27">27</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=28">28</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.DS.IT.DS.DSTERM"><td></td><td><a href="#IG.DS.IT.DS.DSSCAT" title="Subcategory for Disposition Event">DSSCAT</a> = ""</td><td>Reported Term for the Disposition Event</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td>DSDECOD<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.DS.IT.DS.DSDECOD">VLM</a></span></td><td></td><td>Standardized Disposition Term</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">29</td><td></td><td></td></tr><tr class="vlm tablerowodd IG.DS.IT.DS.DSDECOD"><td></td><td><a href="#IG.DS.IT.DS.DSSCAT" title="Subcategory for Disposition Event">DSSCAT</a> ≠ ""</td><td>Standardized Disposition Term</td><td class="datatype">text</td><td class="role"></td><td class="number">29</td><td><a href="#CL.CL.NCOMPLT">Completion/Reason for Non-Completion</a><p class="linebreakcell">
                  [13 Terms]
                </p></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=27">27</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=28">28</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.DS.IT.DS.DSDECOD"><td></td><td><a href="#IG.DS.IT.DS.DSSCAT" title="Subcategory for Disposition Event">DSSCAT</a> = ""</td><td>Standardized Disposition Term</td><td class="datatype">text</td><td class="role"></td><td class="number">29</td><td><span class="linebreakcell"><a href="#CL.CL.PROTMLST">Protocol Milestone</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"INFORMED CONSENT OBTAINED" = "Informed Consent"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.DSCAT"></a>DSCAT</td><td></td><td>Category for Disposition Event</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">18</td><td><span class="linebreakcell"><a href="#CL.CL.DSCAT">Category for Disposition Event</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DISPOSITION EVENT" = "Disposition Event"</li><li class="codelist-item">•&nbsp;"PROTOCOL MILESTONE" = "Protocol Milestone"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=27">27</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=28">28</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">Variable is Assigned but there are annotations to help understand the data and so references to the proper pages are included</p></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.DSSCAT"></a>DSSCAT</td><td></td><td>Subcategory for Disposition Event</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">19</td><td><span class="linebreakcell"><a href="#CL.CL.DSSCAT">Subcategory for Disposition Event</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"STUDY TREATMENT" = "Study Treatment"</li><li class="codelist-item">•&nbsp;"STUDY PARTICIPATION" = "Study Participation"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=27">27</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=28">28</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">Variable is Assigned but there are annotations to help understand the data and so references to the proper pages are included</p></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.DSSTDTC"></a>DSSTDTC</td><td></td><td>Start Date/Time of Disposition Event</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=27">27</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=28">28</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.DSSTDY"></a>DSSTDY</td><td></td><td>Study Day of Start of Disposition Event</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.MH"></a><div class="containerbox"><h1 class="invisible">Medical History (MH) </h1><table summary="ItemGroup IG.IG.MH"><caption><span>MH (Medical History) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="mh.xpt">mh.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.MH.IT.MH.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.MH.IT.MH.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_MH">SDTM Domain Abbreviation, subset used for Medical History</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"MH" = "Medical History"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.MH.IT.MH.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.MH.IT.MH.MHSEQ"></a>MHSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.MH.IT.MH.MHTERM"></a>MHTERM</td><td>Reported Term for the Medical History</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">19</td><td><span class="linebreakcell"><a href="#CL.CL.MHTERM">Medical History Term</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ALZHEIMER'S DISEASE" = "Alzheimer's Disease"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.MH.IT.MH.MHEVDTYP"></a>MHEVDTYP</td><td>Medical History Event Date Type</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">13</td><td><span class="linebreakcell"><a href="#CL.CL.MHEVDTP">Medical History Event Date Type, subset used for MHEVDTP</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SYMPTOM ONSET" = "Symptom Onset"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=7">7</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.MH.IT.MH.MHSTDTC"></a>MHSTDTC</td><td>Start Date/Time of Medical History Event</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=7">7</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.MH.IT.MH.MHSTDY"></a>MHSTDY</td><td>Study Day of Start of Observation</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.DD"></a><div class="containerbox"><h1 class="invisible">Death Details (DD) </h1><table summary="ItemGroup IG.IG.DD"><caption><span>DD (Death Details) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="dd.xpt">dd.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.DD.IT.DD.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DD.IT.DD.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_DD">SDTM Domain Abbreviation, subset used for Death Diagnosis</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DD" = "Death Details"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DD.IT.DD.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DD.IT.DD.DDSEQ"></a>DDSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.DD.IT.DD.DDLNKID"></a>DDLNKID</td><td>Link ID</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">50</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=26">26</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.DD.IT.DD.DDTESTCD"></a>DDTESTCD</td><td>Death Detail Assessment Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.DDTESTCD">Death Details Test Codes</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PRCDTH" = "Primary Cause of Death"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DD.IT.DD.DDTEST"></a>DDTEST</td><td>Death Detail Assessment Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">22</td><td><span class="linebreakcell"><a href="#CL.CL.DDTEST">Death Details Tests</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Primary Cause of Death"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DD.IT.DD.DDORRES"></a>DDORRES</td><td>Result or Finding as Collected</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=26">26</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.DD.IT.DD.DDSTRESC"></a>DDSTRESC</td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Predecessor: DDORRES</div></td></tr><tr class="tableroweven"><td><a id="IG.DD.IT.DD.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.DD.IT.DD.DDDTC"></a>DDDTC</td><td>Date/Time of Collection</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=26">26</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.DD.IT.DD.DDDY"></a>DDDY</td><td>Study Day of Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.FT"></a><div class="containerbox"><h1 class="invisible">Functional Tests (FT) </h1><table summary="ItemGroup IG.IG.FT"><caption><span>FT (Functional Tests) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ft.xpt">ft.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_FT">SDTM Domain Abbreviation, subset used for Functional Tests</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"FT" = "Functional Tests"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.FTSEQ"></a>FTSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.FTTESTCD"></a>FTTESTCD</td><td></td><td>Short Name of Test</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td><a href="#CL.CL.AVL02TC">Rey Auditory Verbal Learning Test Functional Test Code</a><p class="linebreakcell">
                  [34 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.FTTEST"></a>FTTEST</td><td></td><td>Name of Test</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">23</td><td><a href="#CL.CL.AVL02TT">Rey Auditory Verbal Learning Test Functional Test Name</a><p class="linebreakcell">
                  [34 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.FTCAT"></a>FTCAT</td><td></td><td>Category</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.FTCAT">Category of Functional Test, subset used for FTCAT</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AVLT-REY" = "Rey Auditory Verbal Learning Functional Test"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=17">17</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.FTSCAT"></a>FTSCAT</td><td></td><td>Subcategory</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=17">17</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td>FTORRES<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.FT.IT.FT.FTORRES">VLM</a></span></td><td></td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">12</td><td></td><td></td></tr><tr class="vlm tablerowodd IG.FT.IT.FT.FTORRES"><td></td><td><a href="#IG.FT.IT.FT.FTTESTCD" title="Short Name of Test">FTTESTCD</a> IN (<br><span class="linebreakcell">"AVL0201" (AVLT-REY - List A Word 1), </span><br><span class="linebreakcell">"AVL0202" (AVLT-REY - List A Word 2), </span><br><span class="linebreakcell">"AVL0203" (AVLT-REY - List A Word 3), </span><br><span class="linebreakcell">"AVL0204" (AVLT-REY - List A Word 4), </span><br><span class="linebreakcell">"AVL0205" (AVLT-REY - List A Word 5), </span><br><span class="linebreakcell">"AVL0206" (AVLT-REY - List A Word 6), </span><br><span class="linebreakcell">"AVL0207" (AVLT-REY - List A Word 7), </span><br><span class="linebreakcell">"AVL0208" (AVLT-REY - List A Word 8), </span><br><span class="linebreakcell">"AVL0209" (AVLT-REY - List A Word 9), </span><br><span class="linebreakcell">"AVL0210" (AVLT-REY - List A Word 10), </span><br><span class="linebreakcell">"AVL0211" (AVLT-REY - List A Word 11), </span><br><span class="linebreakcell">"AVL0212" (AVLT-REY - List A Word 12), </span><br><span class="linebreakcell">"AVL0213" (AVLT-REY - List A Word 13), </span><br><span class="linebreakcell">"AVL0214" (AVLT-REY - List A Word 14), </span><br><span class="linebreakcell">"AVL0215" (AVLT-REY - List A Word 15)</span><br>) </td><td>AVLT-REY List A Item 1-15</td><td class="datatype">text</td><td class="role"></td><td class="number">12</td><td><span class="linebreakcell"><a href="#CL.CL.AVL02TR">Rey Auditory Verbal Learning Test Functional Test Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"RECALLED" = "Recalled"</li><li class="codelist-item">•&nbsp;"NOT RECALLED" = "Not Recalled"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=17">17</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=18">18</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.FT.IT.FT.FTORRES"><td></td><td><a href="#IG.FT.IT.FT.FTTESTCD" title="Short Name of Test">FTTESTCD</a> IN (<br><span class="linebreakcell">"AVL0216" (AVLT-REY - List A Total), </span><br><span class="linebreakcell">"AVL0217" (AVLT-REY - List A Intrusions)</span><br>) </td><td>AVLT-REY List A Item 16-17</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=17">17</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=18">18</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.FT.IT.FT.FTORRES"><td></td><td><a href="#IG.FT.IT.FT.FTTESTCD" title="Short Name of Test">FTTESTCD</a> IN (<br><span class="linebreakcell">"AVL0218" (AVLT-REY - List B Word 1), </span><br><span class="linebreakcell">"AVL0219" (AVLT-REY - List B Word 2), </span><br><span class="linebreakcell">"AVL0220" (AVLT-REY - List B Word 3), </span><br><span class="linebreakcell">"AVL0221" (AVLT-REY - List B Word 4), </span><br><span class="linebreakcell">"AVL0222" (AVLT-REY - List B Word 5), </span><br><span class="linebreakcell">"AVL0223" (AVLT-REY - List B Word 6), </span><br><span class="linebreakcell">"AVL0224" (AVLT-REY - List B Word 7), </span><br><span class="linebreakcell">"AVL0225" (AVLT-REY - List B Word 8), </span><br><span class="linebreakcell">"AVL0226" (AVLT-REY - List B Word 9), </span><br><span class="linebreakcell">"AVL0227" (AVLT-REY - List B Word 10), </span><br><span class="linebreakcell">"AVL0228" (AVLT-REY - List B Word 11), </span><br><span class="linebreakcell">"AVL0229" (AVLT-REY - List B Word 12), </span><br><span class="linebreakcell">"AVL0230" (AVLT-REY - List B Word 13), </span><br><span class="linebreakcell">"AVL0231" (AVLT-REY - List B Word 14), </span><br><span class="linebreakcell">"AVL0232" (AVLT-REY - List B Word 15)</span><br>) </td><td>AVLT-REY List B Item 18-32</td><td class="datatype">text</td><td class="role"></td><td class="number">12</td><td><span class="linebreakcell"><a href="#CL.CL.AVL02TR">Rey Auditory Verbal Learning Test Functional Test Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"RECALLED" = "Recalled"</li><li class="codelist-item">•&nbsp;"NOT RECALLED" = "Not Recalled"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=17">17</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.FT.IT.FT.FTORRES"><td></td><td><a href="#IG.FT.IT.FT.FTTESTCD" title="Short Name of Test">FTTESTCD</a> IN (<br><span class="linebreakcell">"AVL0233" (AVLT-REY - List B Total), </span><br><span class="linebreakcell">"AVL0234" (AVLT-REY - List B Intrusions)</span><br>) </td><td>AVLT-REY List B Item 33-34</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=17">17</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.FTSTRESC"></a>FTSTRESC</td><td></td><td>Result or Finding in Standard Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Predecessor: FTORRES</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.FTSTRESN"></a>FTSTRESN</td><td></td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">integer</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If FTSTRESC is numeric then FTSTRESN=FTSTRESC in numeric format, else null.</div></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.FTLOBXFL"></a>FTLOBXFL</td><td></td><td>Last Observation Before Exposure Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.FTREPNUM"></a>FTREPNUM</td><td></td><td>Repetition Number</td><td class="datatype">integer</td><td class="role">Record Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=17">17</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=18">18</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.FTDTC"></a>FTDTC</td><td></td><td>Date/Time of Test</td><td class="datatype">partialDatetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=17">17</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=18">18</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">DataType is 'partialDatetime' instead of 'datetime' since datetime values are planned to be collected without seconds for this study.</p></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.FTDY"></a>FTDY</td><td></td><td>Study Day of Test</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.FTTPT"></a>FTTPT</td><td></td><td>Planned Time Point Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.FTTPTNUM"></a>FTTPTNUM</td><td></td><td>Planned Time Point Number</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.FT.IT.FT.FTELTM"></a>FTELTM</td><td></td><td>Planned Elapsed Time from Time Point Ref</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=18">18</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.FT.IT.FT.FTTPTREF"></a>FTTPTREF</td><td></td><td>Time Point Reference</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.IE"></a><div class="containerbox"><h1 class="invisible">Inclusion/Exclusion Criteria Not Met (IE) </h1><table summary="ItemGroup IG.IG.IE"><caption><span>IE (Inclusion/Exclusion Criteria Not Met) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="ie.xpt">ie.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.IE.IT.IE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.IE.IT.IE.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_IE">SDTM Domain Abbreviation, subset used for Inclusion/Exclusion</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"IE" = "Inclusion/Exclusion Criteria Not Met"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.IE.IT.IE.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.IE.IT.IE.IESEQ"></a>IESEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.IE.IT.IE.IETESTCD"></a>IETESTCD</td><td>Inclusion/Exclusion Criterion Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td><a href="#CL.CL.IETESTCD">Incl/Excl Criterion Short Name</a><p class="linebreakcell">
                  [33 Terms]
                </p></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=6">6</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">Please see Appendix 1 of the cSDRG for complete versions of IETESTCD and IETEST.</p></td></tr><tr class="tableroweven"><td><a id="IG.IE.IT.IE.IETEST"></a>IETEST</td><td>Inclusion/Exclusion Criterion</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">196</td><td><a href="#CL.CL.IETEST">Inclusion/Exclusion Criterion</a><p class="linebreakcell">
                  [33 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Please see Appendix 1 of the cSDRG for complete versions of IETESTCD and IETEST.</p></td></tr><tr class="tablerowodd"><td><a id="IG.IE.IT.IE.IECAT"></a>IECAT</td><td>Inclusion/Exclusion Category</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.IECAT">Category for Inclusion/Exclusion</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"EXCLUSION" = "Exclusion"</li><li class="codelist-item">•&nbsp;"INCLUSION" = "Inclusion"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=6">6</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.IE.IT.IE.IEORRES"></a>IEORRES</td><td>I/E Criterion Original Result</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=6">6</a><span class="external-link-gif"></span> ]</p><div class="method-code">If IECAT=INCLUSION then IEORRES=N, else if IECAT=EXCLUSION then IEORRES=Y</div></td></tr><tr class="tablerowodd"><td><a id="IG.IE.IT.IE.IESTRESC"></a>IESTRESC</td><td>I/E Criterion Result in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: IEORRES</div></td></tr><tr class="tableroweven"><td><a id="IG.IE.IT.IE.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.IE.IT.IE.IEDTC"></a>IEDTC</td><td>Date/Time of Collection</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=6">6</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.IE.IT.IE.IEDY"></a>IEDY</td><td>Study Day of Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div><p class="linebreakcell">IEDY is needed if IEDTC is included. Note RFSTDTC is not populated for not randomized subjects then IEDY could not be populated in those cases.</p></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.LB"></a><div class="containerbox"><h1 class="invisible">Laboratory Test Results (LB) </h1><table summary="ItemGroup IG.IG.LB"><caption><span>LB (Laboratory Test Results) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="lb.xpt">lb.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_LB">SDTM Domain Abbreviation, subset used for Laboratory Data</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LB" = "Laboratory Test Results"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBSEQ"></a>LBSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Vendor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBTESTCD"></a>LBTESTCD</td><td></td><td>Lab Test or Examination Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td><a href="#CL.CL.LBTESTCD">Laboratory Test Code</a><p class="linebreakcell">
                  [40 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBTEST"></a>LBTEST</td><td></td><td>Lab Test or Examination Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">39</td><td><a href="#CL.CL.LBTEST">Laboratory Test Name</a><p class="linebreakcell">
                  [40 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBCAT"></a>LBCAT</td><td></td><td>Category for Lab Test</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">10</td><td><span class="linebreakcell"><a href="#CL.CL.LBCAT">Laboratory Test Category</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CHEMISTRY" = "Chemistry"</li><li class="codelist-item">•&nbsp;"HEMATOLOGY" = "Hematology"</li><li class="codelist-item">•&nbsp;"URINALYSIS" = "Urinalysis"</li><li class="codelist-item">•&nbsp;"OTHER" = "Other"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="tableroweven"><td>LBORRES<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.LB.IT.LB.LBORRES">VLM</a></span></td><td></td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">6</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"ALB" (Albumin Measurement), </span><br><span class="linebreakcell">"BILI" (Total Bilirubin Measurement), </span><br><span class="linebreakcell">"CA" (Calcium Measurement), </span><br><span class="linebreakcell">"CREAT" (Creatinine Measurement), </span><br><span class="linebreakcell">"K" (Potassium Measurement), </span><br><span class="linebreakcell">"PHOS" (Phosphate Measurement), </span><br><span class="linebreakcell">"PROT" (Total Protein Measurement), </span><br><span class="linebreakcell">"URATE" (Urate Measurement)</span><br>) </td><td>Lab Result or Finding in Original Units - Set 1</td><td class="datatype">float</td><td class="role"></td><td class="number">3</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"HCT" (Hematocrit Measurement), </span><br><span class="linebreakcell">"HGB" (Hemoglobin Measurement)</span><br>) </td><td>Lab Result or Finding in Original Units - Set 2</td><td class="datatype">float</td><td class="role"></td><td class="number">4</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"BASO" (Total Basophil Count), </span><br><span class="linebreakcell">"EOS" (Eosinophil Count), </span><br><span class="linebreakcell">"LYM" (Lymphocyte Count), </span><br><span class="linebreakcell">"MONO" (Monocyte Count), </span><br><span class="linebreakcell">"RBC" (Erythrocyte Count), </span><br><span class="linebreakcell">"TSH" (Thyrotropin Measurement), </span><br><span class="linebreakcell">"WBC" (Leukocyte Count)</span><br>) </td><td>Lab Result or Finding in Original Units - Set 3</td><td class="datatype">float</td><td class="role"></td><td class="number">5</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "SPGRAV" (Specific Gravity)</td><td>Lab Result or Finding in Original Units - Specific Gravity</td><td class="datatype">float</td><td class="role"></td><td class="number">5</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"ANISO" (Anisocyte Measurement), </span><br><span class="linebreakcell">"KETONES" (Ketone Measurement), </span><br><span class="linebreakcell">"MACROCY" (Macrocyte Count), </span><br><span class="linebreakcell">"PH" (pH), </span><br><span class="linebreakcell">"POIKILO" (Poikilocyte Measurement), </span><br><span class="linebreakcell">"UROBIL" (Urobilinogen Measurement)</span><br>) </td><td>Lab Result or Finding in Original Units - Set 4</td><td class="datatype">integer</td><td class="role"></td><td class="number">1</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"ALT" (Alanine Aminotransferase Measurement), </span><br><span class="linebreakcell">"AST" (Aspartate Aminotransferase Measurement), </span><br><span class="linebreakcell">"GGT" (Gamma Glutamyl Transpeptidase Measurement), </span><br><span class="linebreakcell">"MCH" (Erythrocyte Mean Corpuscular Hemoglobin), </span><br><span class="linebreakcell">"MCHC" (Erythrocyte Mean Corpuscular Hemoglobin Concentration), </span><br><span class="linebreakcell">"MCV" (Erythrocyte Mean Corpuscular Volume), </span><br><span class="linebreakcell">"UREAN" (Urea Nitrogen Measurement)</span><br>) </td><td>Lab Result or Finding in Original Units - Set 5</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"ALP" (Alkaline Phosphatase Measurement), </span><br><span class="linebreakcell">"CHOL" (Cholesterol Measurement), </span><br><span class="linebreakcell">"CK" (Creatine Kinase Measurement), </span><br><span class="linebreakcell">"CL" (Chloride Measurement), </span><br><span class="linebreakcell">"PLAT" (Platelet Count), </span><br><span class="linebreakcell">"SODIUM" (Sodium Measurement), </span><br><span class="linebreakcell">"VITB12" (Vitamin B12 Measurement)</span><br>) </td><td>Lab Result or Finding in Original Units - Set 6</td><td class="datatype">integer</td><td class="role"></td><td class="number">4</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "COLOR" (Color Assessment)</td><td>Lab Result or Finding in Original Units - Color</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBORRES"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "GLUC" (Glucose Measurement)</td><td>Lab Result or Finding in Original Units - Glucose</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td></td><td></td></tr><tr class="tablerowodd"><td>LBORRESU<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.LB.IT.LB.LBORRESU">VLM</a></span></td><td></td><td>Original Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "ALT" (Alanine Aminotransferase Measurement)</td><td>Lab Result Units - ALT</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "ALB" (Albumin Measurement)</td><td>Lab Result Units - ALB</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_g/dL">Unit, subset to be used in VLM for tests with g/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"g/dL" = "Gram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "ALP" (Alkaline Phosphatase Measurement)</td><td>Lab Result Units - ALP</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "AST" (Aspartate Aminotransferase Measurement)</td><td>Lab Result Units - AST</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "BASO" (Total Basophil Count)</td><td>Lab Result Units - BASO</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "BILI" (Total Bilirubin Measurement)</td><td>Lab Result Units - BILI</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg/dL" = "Milligram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CA" (Calcium Measurement)</td><td>Lab Result Units - CA</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg/dL" = "Milligram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CL" (Chloride Measurement)</td><td>Lab Result Units - CL</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mEq/L">Unit, subset to be used in VLM for tests with mEq/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mEq/L" = "Milliequivalent Per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CHOL" (Cholesterol Measurement)</td><td>Lab Result Units - CHOL</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg/dL" = "Milligram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CK" (Creatine Kinase Measurement)</td><td>Lab Result Units - CK</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CREAT" (Creatinine Measurement)</td><td>Lab Result Units - CREAT</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg/dL" = "Milligram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "EOS" (Eosinophil Count)</td><td>Lab Result Units - EOS</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MCH" (Erythrocyte Mean Corpuscular Hemoglobin)</td><td>Lab Result Units - MCH</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_pg">Unit, subset to be used in VLM for tests with pg as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"pg" = "Picogram"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MCHC" (Erythrocyte Mean Corpuscular Hemoglobin Concentration)</td><td>Lab Result Units - MCHC</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_g/dL">Unit, subset to be used in VLM for tests with g/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"g/dL" = "Gram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MCV" (Erythrocyte Mean Corpuscular Volume)</td><td>Lab Result Units - MCV</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_fL">Unit, subset to be used in VLM for tests with fL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"fL" = "Femtoliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "RBC" (Erythrocyte Count)</td><td>Lab Result Units - RBC</td><td class="datatype">text</td><td class="role"></td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^12/L">Unit, subset to be used in VLM for tests with 10^12/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^12/L" = "Million per Microliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "GGT" (Gamma Glutamyl Transpeptidase Measurement)</td><td>Lab Result Units - GGT</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "GLUC" (Glucose Measurement)</td><td>Lab Result Units - GLUC</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg/dL" = "Milligram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "HCT" (Hematocrit Measurement)</td><td>Lab Result Units - HCT</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_PCT">Unit, subset to be used in VLM for tests with % as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"%" = "Percentage"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "HGB" (Hemoglobin Measurement)</td><td>Lab Result Units - HGB</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_g/dL">Unit, subset to be used in VLM for tests with g/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"g/dL" = "Gram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "WBC" (Leukocyte Count)</td><td>Lab Result Units - WBC</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "LYM" (Lymphocyte Count)</td><td>Lab Result Units - LYM</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MONO" (Monocyte Count)</td><td>Lab Result Units - MONO</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "PHOS" (Phosphate Measurement)</td><td>Lab Result Units - PHOS</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg/dL" = "Milligram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "PLAT" (Platelet Count)</td><td>Lab Result Units - PLAT</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "K" (Potassium Measurement)</td><td>Lab Result Units - K</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mEq/L">Unit, subset to be used in VLM for tests with mEq/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mEq/L" = "Milliequivalent Per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "PROT" (Total Protein Measurement)</td><td>Lab Result Units - PROT</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_g/dL">Unit, subset to be used in VLM for tests with g/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"g/dL" = "Gram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "SODIUM" (Sodium Measurement)</td><td>Lab Result Units - SODIUM</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mEq/L">Unit, subset to be used in VLM for tests with mEq/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mEq/L" = "Milliequivalent Per Liter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "TSH" (Thyrotropin Measurement)</td><td>Lab Result Units - TSH</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mIU/L">Unit, subset to be used in VLM for tests with mIU/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mIU/L" = "Microinternational Unit per Milliliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "URATE" (Urate Measurement)</td><td>Lab Result Units - URATE</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg/dL" = "Milligram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "UREAN" (Urea Nitrogen Measurement)</td><td>Lab Result Units - UREAN</td><td class="datatype">text</td><td class="role"></td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mg/dL">Unit, subset to be used in VLM for tests with mg/dL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mg/dL" = "Milligram per Deciliter"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.LB.IT.LB.LBORRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "VITB12" (Vitamin B12 Measurement)</td><td>Lab Result Units - VITB12</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_ng/L">Unit, subset to be used in VLM for tests with ng/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ng/L" = "Nanogram per Liter"</li></ul></td><td></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBORNRLO"></a>LBORNRLO</td><td></td><td>Reference Range Lower Limit in Orig Unit</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBORNRHI"></a>LBORNRHI</td><td></td><td>Reference Range Upper Limit in Orig Unit</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="tableroweven"><td>LBSTRESC<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.LB.IT.LB.LBSTRESC">VLM</a></span></td><td></td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Vendor</span>)</div><div class="method-code">LBSTRESC is equal to LBORRES or the value in standard units if a conversion is necessary.</div></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "K" (Potassium Measurement)</td><td>Character Result/Finding in Std Format - K</td><td class="datatype">float</td><td class="role"></td><td class="number">2</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "RBC" (Erythrocyte Count)</td><td>Character Result/Finding in Std Format - RBC</td><td class="datatype">float</td><td class="role"></td><td class="number">3</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"BASO" (Total Basophil Count), </span><br><span class="linebreakcell">"EOS" (Eosinophil Count), </span><br><span class="linebreakcell">"LYM" (Lymphocyte Count), </span><br><span class="linebreakcell">"MONO" (Monocyte Count), </span><br><span class="linebreakcell">"RBC" (Erythrocyte Count), </span><br><span class="linebreakcell">"TSH" (Thyrotropin Measurement), </span><br><span class="linebreakcell">"WBC" (Leukocyte Count)</span><br>) </td><td>Character Result/Finding in Std Format - Set 1</td><td class="datatype">float</td><td class="role"></td><td class="number">3</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "BILI" (Total Bilirubin Measurement)</td><td>Character Result/Finding in Std Format - BILI</td><td class="datatype">float</td><td class="role"></td><td class="number">4</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"SPGRAV" (Specific Gravity), </span><br><span class="linebreakcell">"UREAN" (Urea Nitrogen Measurement)</span><br>) </td><td>Character Result/Finding in Std Format - Set 2</td><td class="datatype">float</td><td class="role"></td><td class="number">4</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CREAT" (Creatinine Measurement)</td><td>Character Result/Finding in Std Format - CREAT</td><td class="datatype">float</td><td class="role"></td><td class="number">5</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "URATE" (Urate Measurement)</td><td>Character Result/Finding in Std Format - URATE</td><td class="datatype">float</td><td class="role"></td><td class="number">6</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MCHC" (Erythrocyte Mean Corpuscular Hemoglobin Concentration)</td><td>Character Result/Finding in Std Format - MCHC</td><td class="datatype">float</td><td class="role"></td><td class="number">6</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"CA" (Calcium Measurement), </span><br><span class="linebreakcell">"CHOL" (Cholesterol Measurement), </span><br><span class="linebreakcell">"MCH" (Erythrocyte Mean Corpuscular Hemoglobin), </span><br><span class="linebreakcell">"PHOS" (Phosphate Measurement)</span><br>) </td><td>Character Result/Finding in Std Format - Set 3</td><td class="datatype">float</td><td class="role"></td><td class="number">6</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "VITB12" (Vitamin B12 Measurement)</td><td>Character Result/Finding in Std Format - VITB12</td><td class="datatype">float</td><td class="role"></td><td class="number">7</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "HGB" (Hemoglobin Measurement)</td><td>Character Result/Finding in Std Format - HGB</td><td class="datatype">float</td><td class="role"></td><td class="number">7</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"ANISO" (Anisocyte Measurement), </span><br><span class="linebreakcell">"KETONES" (Ketone Measurement), </span><br><span class="linebreakcell">"MACROCY" (Macrocyte Count), </span><br><span class="linebreakcell">"PH" (pH), </span><br><span class="linebreakcell">"POIKILO" (Poikilocyte Measurement), </span><br><span class="linebreakcell">"UROBIL" (Urobilinogen Measurement)</span><br>) </td><td>Character Result/Finding in Std Format - Set 4</td><td class="datatype">integer</td><td class="role"></td><td class="number">1</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"ALB" (Albumin Measurement), </span><br><span class="linebreakcell">"ALT" (Alanine Aminotransferase Measurement), </span><br><span class="linebreakcell">"AST" (Aspartate Aminotransferase Measurement), </span><br><span class="linebreakcell">"GGT" (Gamma Glutamyl Transpeptidase Measurement), </span><br><span class="linebreakcell">"PROT" (Total Protein Measurement)</span><br>) </td><td>Character Result/Finding in Std Format - Set 5</td><td class="datatype">integer</td><td class="role"></td><td class="number">2</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> IN (<br><span class="linebreakcell">"ALP" (Alkaline Phosphatase Measurement), </span><br><span class="linebreakcell">"CL" (Chloride Measurement), </span><br><span class="linebreakcell">"MCV" (Erythrocyte Mean Corpuscular Volume), </span><br><span class="linebreakcell">"PLAT" (Platelet Count), </span><br><span class="linebreakcell">"SODIUM" (Sodium Measurement)</span><br>) </td><td>Character Result/Finding in Std Format - Set 6</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CK" (Creatine Kinase Measurement)</td><td>Character Result/Finding in Std Format - CK</td><td class="datatype">integer</td><td class="role"></td><td class="number">4</td><td></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "COLOR" (Color Assessment)</td><td>Character Result/Finding in Std Format - COLOR</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NORMABNM">Normal Abnormal Response, subset used in OE and NV.</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ABNORMAL" = "Abnormal"</li><li class="codelist-item">•&nbsp;"NORMAL" = "Normal"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESC"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "GLUC" (Glucose Measurement)</td><td>Character Result/Finding in Std Format - GLUC</td><td class="datatype">text</td><td class="role"></td><td class="number">8</td><td></td><td></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBSTRESN"></a>LBSTRESN</td><td></td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">float</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Vendor</span>)</div><div class="method-code">If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code.</div></td></tr><tr class="tableroweven"><td>LBSTRESU<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.LB.IT.LB.LBSTRESU">VLM</a></span></td><td></td><td>Standard Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "ALT" (Alanine Aminotransferase Measurement)</td><td>Lab Result Standard Units - ALT</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "ALB" (Albumin Measurement)</td><td>Lab Result Standard Units - ALB</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_g/L">Unit, subset to be used in VLM for tests with g/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"g/L" = "Femtomole"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "ALP" (Alkaline Phosphatase Measurement)</td><td>Lab Result Standard Units - ALP</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "AST" (Aspartate Aminotransferase Measurement)</td><td>Lab Result Standard Units - AST</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "BASO" (Total Basophil Count)</td><td>Lab Result Standard Units - BASO</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "BILI" (Total Bilirubin Measurement)</td><td>Lab Result Standard Units - BILI</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_umol/L">Unit, subset to be used in VLM for tests with umol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"umol/L" = "Micromole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CA" (Calcium Measurement)</td><td>Lab Result Standard Units - CA</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CL" (Chloride Measurement)</td><td>Lab Result Standard Units - CL</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CHOL" (Cholesterol Measurement)</td><td>Lab Result Standard Units - CHOL</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CK" (Creatine Kinase Measurement)</td><td>Lab Result Standard Units - CK</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "CREAT" (Creatinine Measurement)</td><td>Lab Result Standard Units - CREAT</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_umol/L">Unit, subset to be used in VLM for tests with umol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"umol/L" = "Micromole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "EOS" (Eosinophil Count)</td><td>Lab Result Standard Units - EOS</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MCH" (Erythrocyte Mean Corpuscular Hemoglobin)</td><td>Lab Result Standard Units - MCH</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_fmol">Unit, subset to be used in VLM for tests with fmol as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"fmol" = "Femtomole"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MCHC" (Erythrocyte Mean Corpuscular Hemoglobin Concentration)</td><td>Lab Result Standard Units - MCHC</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MCV" (Erythrocyte Mean Corpuscular Volume)</td><td>Lab Result Standard Units - MCV</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_fL">Unit, subset to be used in VLM for tests with fL as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"fL" = "Femtoliter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "RBC" (Erythrocyte Count)</td><td>Lab Result Standard Units - RBC</td><td class="datatype">text</td><td class="role"></td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^12/L">Unit, subset to be used in VLM for tests with 10^12/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^12/L" = "Million per Microliter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "GGT" (Gamma Glutamyl Transpeptidase Measurement)</td><td>Lab Result Standard Units - GGT</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_U/L">Unit, subset to be used in VLM for tests with U/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"U/L" = "Unit per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "GLUC" (Glucose Measurement)</td><td>Lab Result Standard Units - GLUC</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "HGB" (Hemoglobin Measurement)</td><td>Lab Result Standard Units - HGB</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "WBC" (Leukocyte Count)</td><td>Lab Result Standard Units - WBC</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "LYM" (Lymphocyte Count)</td><td>Lab Result Standard Units - LYM</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "MONO" (Monocyte Count)</td><td>Lab Result Standard Units - MONO</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "PHOS" (Phosphate Measurement)</td><td>Lab Result Standard Units - PHOS</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "PLAT" (Platelet Count)</td><td>Lab Result Standard Units - PLAT</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_10^9/L">Unit, subset to be used in VLM for tests with 10^9/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"10^9/L" = "Billion per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "K" (Potassium Measurement)</td><td>Lab Result Standard Units - K</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "PROT" (Total Protein Measurement)</td><td>Lab Result Standard Units - PROT</td><td class="datatype">text</td><td class="role"></td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_g/L">Unit, subset to be used in VLM for tests with g/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"g/L" = "Femtomole"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "SODIUM" (Sodium Measurement)</td><td>Lab Result Standard Units - SODIUM</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "TSH" (Thyrotropin Measurement)</td><td>Lab Result Standard Units - TSH</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mU/L">Unit, subset to be used in VLM for tests with mU/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mU/L" = "Microunit per Milliliter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "URATE" (Urate Measurement)</td><td>Lab Result Standard Units - URATE</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_umol/L">Unit, subset to be used in VLM for tests with umol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"umol/L" = "Micromole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "UREAN" (Urea Nitrogen Measurement)</td><td>Lab Result Standard Units - UREAN</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_mmol/L">Unit, subset to be used in VLM for tests with mmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmol/L" = "Millimole per Liter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.LB.IT.LB.LBSTRESU"><td></td><td><a href="#IG.LB.IT.LB.LBTESTCD" title="Lab Test or Examination Short Name">LBTESTCD</a> = "VITB12" (Vitamin B12 Measurement)</td><td>Lab Result Standard Units - VITB12</td><td class="datatype">text</td><td class="role"></td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.UNIT_LB_pmol/L">Unit, subset to be used in VLM for tests with pmol/L as the unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"pmol/L" = "Picomole per Liter"</li></ul></td><td></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBSTNRLO"></a>LBSTNRLO</td><td></td><td>Reference Range Lower Limit-Std Units</td><td class="datatype">float</td><td class="role">Variable Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBSTNRHI"></a>LBSTNRHI</td><td></td><td>Reference Range Upper Limit-Std Units</td><td class="datatype">float</td><td class="role">Variable Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBNRIND"></a>LBNRIND</td><td></td><td>Reference Range Indicator</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.NRIND">Normal Range Indicator</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ABNORMAL" = "Abnormal"</li><li class="codelist-item">•&nbsp;"HIGH" = "High"</li><li class="codelist-item">•&nbsp;"LOW" = "Low"</li><li class="codelist-item">•&nbsp;"NORMAL" = "Normal"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBLOBXFL"></a>LBLOBXFL</td><td></td><td>Last Observation Before Exposure Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Vendor</span>)</div><div class="method-code">Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Vendor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBDTC"></a>LBDTC</td><td></td><td>Date/Time of Specimen Collection</td><td class="datatype">partialDatetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Vendor</span>)</div><p class="linebreakcell">DataType is 'partialDatetime' instead of 'datetime' since datetime values are planned to be collected without seconds for this study.</p></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBDY"></a>LBDY</td><td></td><td>Study Day of Specimen Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Vendor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.NV"></a><div class="containerbox"><h1 class="invisible">Nervous System Findings (NV) </h1><table summary="ItemGroup IG.IG.NV"><caption><span>NV (Nervous System Findings) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="nodata">[No Data]</span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPNV">SUPPNV</a> (Supplemental Qualifiers for NV)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.NV.IT.NV.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.NV.IT.NV.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_NV">SDTM Domain Abbreviation, subset used for Nervous System Findings</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"NV" = "Nervous Sysytem Findings"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.NV.IT.NV.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.NV.IT.NV.NVSEQ"></a>NVSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.NV.IT.NV.NVTESTCD"></a>NVTESTCD</td><td>Short Name of Nervous System Test</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.NVTESTCD">Nervous System Test Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"INTP" = "Interpretation"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.NV.IT.NV.NVTEST"></a>NVTEST</td><td>Name of Nervous System Test</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">14</td><td><span class="linebreakcell"><a href="#CL.CL.NVTEST">Nervous System Test</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Interpretation"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.NV.IT.NV.NVORRES"></a>NVORRES</td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.NORMABNM">Normal Abnormal Response, subset used in OE and NV.</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ABNORMAL" = "Abnormal"</li><li class="codelist-item">•&nbsp;"NORMAL" = "Normal"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=20">20</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.NV.IT.NV.NVSTRESC"></a>NVSTRESC</td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.NORMABNM">Normal Abnormal Response, subset used in OE and NV.</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ABNORMAL" = "Abnormal"</li><li class="codelist-item">•&nbsp;"NORMAL" = "Normal"</li></ul></td><td><div class="linebreakcell">Predecessor: NVORRES</div></td></tr><tr class="tablerowodd"><td><a id="IG.NV.IT.NV.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.NV.IT.NV.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.NV.IT.NV.NVDTC"></a>NVDTC</td><td>Date/Time of Collection</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=20">20</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.NV.IT.NV.NVDY"></a>NVDY</td><td>Study Day of Visit/Collection/Exam</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.OE"></a><div class="containerbox"><h1 class="invisible">Ophthalmic Examinations (OE) </h1><table summary="ItemGroup IG.IG.OE"><caption><span>OE (Ophthalmic Examinations) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="oe.xpt">oe.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPOE">SUPPOE</a> (Supplemental Qualifiers for OE)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.OE.IT.OE.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_OE">SDTM Domain Abbreviation, subset used for Ophthalmic Examinations</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"OE" = "Ophthalmic Examinations"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.OE.IT.OE.FOCID"></a>FOCID</td><td></td><td>Focus of Study-Specific Interest</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.OEFOCUS">Ophthalmic Focus of Study Specific Interest</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"OD" = "Right Eye"</li><li class="codelist-item">•&nbsp;"OS" = "Left Eye"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=21">21</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.OESEQ"></a>OESEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tableroweven"><td><a id="IG.OE.IT.OE.OETESTCD"></a>OETESTCD</td><td></td><td>Short Name of Ophthalmic Test or Exam</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.OETESTCD">Ophthalmic Exam Test Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ABDETAIL" = "Abnormality Detail"</li><li class="codelist-item">•&nbsp;"INTP" = "Interpretation"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.OETEST"></a>OETEST</td><td></td><td>Name of Ophthalmic Test or Exam</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">18</td><td><span class="linebreakcell"><a href="#CL.CL.OETEST">Ophthalmic Exam Test</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Abnormality Detail"</li><li class="codelist-item">•&nbsp;"Interpretation"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td>OEORRES<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.OE.IT.OE.OEORRES">VLM</a></span></td><td></td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=21">21</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.OE.IT.OE.OEORRES"><td></td><td><a href="#IG.OE.IT.OE.OETESTCD" title="Short Name of Ophthalmic Test or Exam">OETESTCD</a> = "INTP" (Interpretation)</td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.NORMABNM">Normal Abnormal Response, subset used in OE and NV.</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ABNORMAL" = "Abnormal"</li><li class="codelist-item">•&nbsp;"NORMAL" = "Normal"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.OE.IT.OE.OEORRES"><td></td><td><a href="#IG.OE.IT.OE.OETESTCD" title="Short Name of Ophthalmic Test or Exam">OETESTCD</a> = "ABDETAIL" (Abnormality Detail)</td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td></td></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.OESTRESC"></a>OESTRESC</td><td></td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Predecessor: OEORRES</div></td></tr><tr class="tableroweven"><td><a id="IG.OE.IT.OE.OELOC"></a>OELOC</td><td></td><td>Location Used for the Measurement</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">21</td><td><span class="linebreakcell"><a href="#CL.CL.LOC_OE">Anatomical Location, subset used for OELOC</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CONJUNCTIVA" = "Conjunctiva"</li><li class="codelist-item">•&nbsp;"EYE" = "Eye"</li><li class="codelist-item">•&nbsp;"EYE, ANTERIOR CHAMBER" = "Anterior Chamber of the Eye"</li><li class="codelist-item">•&nbsp;"IRIS" = "Iris"</li><li class="codelist-item">•&nbsp;"CORNEA" = "Cornea"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=21">21</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.OELAT"></a>OELAT</td><td></td><td>Laterality</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.LAT_OE">Laterality, subset to be used in OE</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LEFT" = "Left"</li><li class="codelist-item">•&nbsp;"RIGHT" = "Right"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=21">21</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.OE.IT.OE.OEMETHOD"></a>OEMETHOD</td><td></td><td>Method of Test or Examination</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.OEMETHOD">Method, subset used for OEMETHOD</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SLIT LAMP" = "Slit-lamp Examination"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=21">21</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.OELOBXFL"></a>OELOBXFL</td><td></td><td>Last Observation Before Exposure Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.</div></td></tr><tr class="tableroweven"><td><a id="IG.OE.IT.OE.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=21">21</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.OE.IT.OE.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.OE.IT.OE.OEDTC"></a>OEDTC</td><td></td><td>Date/Time of Collection</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=21">21</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.OE.IT.OE.OEDY"></a>OEDY</td><td></td><td>Study Day of Visit/Collection/Exam</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.QSPH"></a><div class="containerbox"><h1 class="invisible">Questionnaires (PHQ-9) (QSPH) </h1><table summary="ItemGroup IG.IG.QSPH"><caption><span>QSPH (Questionnaires (PHQ-9), Questionnaires) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="qsph.xpt">qsph.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.QSPH.IT.QSPH.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSPH.IT.QSPH.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_QS">SDTM Domain Abbreviation, subset used for Questionnaires</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"QS" = "Questionnaires"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSPH.IT.QSPH.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSPH.IT.QSPH.QSSEQ"></a>QSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSPH.IT.QSPH.QSTESTCD"></a>QSTESTCD</td><td></td><td>Question Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td><a href="#CL.CL.PHQ01C">Patient Health Questionnaire - 9 Item Questionnaire Test Code</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSPH.IT.QSPH.QSTEST"></a>QSTEST</td><td></td><td>Question Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">40</td><td><a href="#CL.CL.PHQ01T">Patient Health Questionnaire - 9 Item Questionnaire Test Name</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSPH.IT.QSPH.QSCAT"></a>QSCAT</td><td></td><td>Category of Question</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.QSCAT_PH">Category of Questionnaire for PHQ-9</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"PHQ-9" = "Patient Health Questionnaire - 9 Item"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=15">15</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td>QSORRES<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.QSPH.IT.QSPH.QSORRES">VLM</a></span></td><td></td><td>Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">23</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=15">15</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.QSPH.IT.QSPH.QSORRES"><td></td><td><a href="#IG.QSPH.IT.QSPH.QSTESTCD" title="Question Short Name">QSTESTCD</a> IN (<br><span class="linebreakcell">"PHQ0101" (PHQ01-Little Interest/Pleasure in Things), </span><br><span class="linebreakcell">"PHQ0102" (PHQ01-Feeling Down Depressed or Hopeless), </span><br><span class="linebreakcell">"PHQ0103" (PHQ01-Trouble Falling or Staying Asleep), </span><br><span class="linebreakcell">"PHQ0104" (PHQ01-Feeling Tired or Little Energy), </span><br><span class="linebreakcell">"PHQ0105" (PHQ01-Poor Appetite or Overeating), </span><br><span class="linebreakcell">"PHQ0106" (PHQ01-Feeling Bad About Yourself), </span><br><span class="linebreakcell">"PHQ0107" (PHQ01-Trouble Concentrating on Things), </span><br><span class="linebreakcell">"PHQ0108" (PHQ01-Moving Slowly or Fidgety/Restless), </span><br><span class="linebreakcell">"PHQ0109" (PHQ01-Thoughts You Be Better Off Dead)</span><br>) </td><td>PHQ-9 Questions 1-9</td><td class="datatype">text</td><td class="role"></td><td class="number">23</td><td><span class="linebreakcell"><a href="#CL.CL.PHQ01R">Patient Health Questionnaire Responses</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Not at all"</li><li class="codelist-item">•&nbsp;"Several days"</li><li class="codelist-item">•&nbsp;"More than half the days"</li><li class="codelist-item">•&nbsp;"Nearly every day"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.QSPH.IT.QSPH.QSORRES"><td></td><td><a href="#IG.QSPH.IT.QSPH.QSTESTCD" title="Question Short Name">QSTESTCD</a> = "PHQ0110" (PHQ01-Difficult to Work/Take Care Things)</td><td>PHQ-9 Question 10</td><td class="datatype">text</td><td class="role"></td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.PHQ01RQ10">Patient Health Questionnaire Responses-Question 10</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Not difficult at all"</li><li class="codelist-item">•&nbsp;"Somewhat difficult"</li><li class="codelist-item">•&nbsp;"Very difficult"</li><li class="codelist-item">•&nbsp;"Extremely Difficult"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.QSPH.IT.QSPH.QSORRES"><td></td><td><a href="#IG.QSPH.IT.QSPH.QSTESTCD" title="Question Short Name">QSTESTCD</a> = "PHQ0111" (PHQ01-Total Score)</td><td>PHQ-9 Question Total</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td></td></tr><tr class="tablerowodd"><td>QSSTRESC<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.QSPH.IT.QSPH.QSSTRESC">VLM</a></span></td><td></td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">20</td><td></td><td></td></tr><tr class="vlm tablerowodd IG.QSPH.IT.QSPH.QSSTRESC"><td></td><td><a href="#IG.QSPH.IT.QSPH.QSTESTCD" title="Question Short Name">QSTESTCD</a> IN (<br><span class="linebreakcell">"PHQ0101" (PHQ01-Little Interest/Pleasure in Things), </span><br><span class="linebreakcell">"PHQ0102" (PHQ01-Feeling Down Depressed or Hopeless), </span><br><span class="linebreakcell">"PHQ0103" (PHQ01-Trouble Falling or Staying Asleep), </span><br><span class="linebreakcell">"PHQ0104" (PHQ01-Feeling Tired or Little Energy), </span><br><span class="linebreakcell">"PHQ0105" (PHQ01-Poor Appetite or Overeating), </span><br><span class="linebreakcell">"PHQ0106" (PHQ01-Feeling Bad About Yourself), </span><br><span class="linebreakcell">"PHQ0107" (PHQ01-Trouble Concentrating on Things), </span><br><span class="linebreakcell">"PHQ0108" (PHQ01-Moving Slowly or Fidgety/Restless), </span><br><span class="linebreakcell">"PHQ0109" (PHQ01-Thoughts You Be Better Off Dead)</span><br>) </td><td>PHQ-9 Questions 1-9, Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.PHQ01RS">Patient Health Questionnaire Responses Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Not at all"</li><li class="codelist-item">•&nbsp;1 = "Several days"</li><li class="codelist-item">•&nbsp;2 = "More than half the days"</li><li class="codelist-item">•&nbsp;3 = "Nearly every day"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=15">15</a><span class="external-link-gif"></span> ]</p><div class="method-code">If QSORRES="Not at all" then 0
If QSORRES="Several days" then 1
If QSORRES="More than half the days" then 2
If QSORRES="Nearly every day" then 3</div></td></tr><tr class="vlm tablerowodd IG.QSPH.IT.QSPH.QSSTRESC"><td></td><td><a href="#IG.QSPH.IT.QSPH.QSTESTCD" title="Question Short Name">QSTESTCD</a> = "PHQ0110" (PHQ01-Difficult to Work/Take Care Things)</td><td>PHQ-9 Question 10, Standardized</td><td class="datatype">text</td><td class="role"></td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.PHQ01RQ10">Patient Health Questionnaire Responses-Question 10</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Not difficult at all"</li><li class="codelist-item">•&nbsp;"Somewhat difficult"</li><li class="codelist-item">•&nbsp;"Very difficult"</li><li class="codelist-item">•&nbsp;"Extremely Difficult"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=15">15</a><span class="external-link-gif"></span> ]</p><div class="method-code">QSSTRESC=QSORRES</div></td></tr><tr class="vlm tablerowodd IG.QSPH.IT.QSPH.QSSTRESC"><td></td><td><a href="#IG.QSPH.IT.QSPH.QSTESTCD" title="Question Short Name">QSTESTCD</a> = "PHQ0111" (PHQ01-Total Score)</td><td>PHQ-9 Question Total, Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: QSORRES where QSTESTCD EQ PHQ0111</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=15">15</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.QSPH.IT.QSPH.QSSTRESN"></a>QSSTRESN</td><td></td><td>Numeric Finding in Standard Units</td><td class="datatype">integer</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=15">15</a><span class="external-link-gif"></span> ]</p><div class="method-code">If QSSTRESC is numeric then QSSTRESN=QSSTRESC in numeric format, else null.</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSPH.IT.QSPH.QSLOBXFL"></a>QSLOBXFL</td><td></td><td>Last Observation Before Exposure Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.</div></td></tr><tr class="tableroweven"><td><a id="IG.QSPH.IT.QSPH.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSPH.IT.QSPH.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSPH.IT.QSPH.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSPH.IT.QSPH.QSDTC"></a>QSDTC</td><td></td><td>Date/Time of Finding</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSPH.IT.QSPH.QSDY"></a>QSDY</td><td></td><td>Study Day of Finding</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSPH.IT.QSPH.QSEVLINT"></a>QSEVLINT</td><td></td><td>Evaluation Interval</td><td class="datatype">durationDatetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=15">15</a><span class="external-link-gif"></span> ]</p></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.QSSL"></a><div class="containerbox"><h1 class="invisible">Questionnaires (SQLS) (QSSL) </h1><table summary="ItemGroup IG.IG.QSSL"><caption><span>QSSL (Questionnaires (SQLS), Questionnaires) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="qssl.xpt">qssl.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.QSSL.IT.QSSL.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSSL.IT.QSSL.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_QS">SDTM Domain Abbreviation, subset used for Questionnaires</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"QS" = "Questionnaires"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSSL.IT.QSSL.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSSL.IT.QSSL.QSSEQ"></a>QSSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSSL.IT.QSSL.QSTESTCD"></a>QSTESTCD</td><td>Question Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.SWLS01TC">Satisfaction With Life Scale Questionnaire Test Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SWLS0101" = "SWLS01-Have Gotten Important Things"</li><li class="codelist-item">•&nbsp;"SWLS0102" = "SWLS01-I Am Satisfied with My Life"</li><li class="codelist-item">•&nbsp;"SWLS0103" = "SWLS01-Live Life Over Change Nothing"</li><li class="codelist-item">•&nbsp;"SWLS0104" = "SWLS01-My Life Conditions are Excellent"</li><li class="codelist-item">•&nbsp;"SWLS0105" = "SWLS01-My Life is Close to Ideal"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSSL.IT.QSSL.QSTEST"></a>QSTEST</td><td>Question Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">39</td><td><span class="linebreakcell"><a href="#CL.CL.SWLS01TN">Satisfaction With Life Scale Questionnaire Test Name</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SWLS01-Have Gotten Important Things"</li><li class="codelist-item">•&nbsp;"SWLS01-I Am Satisfied with My Life"</li><li class="codelist-item">•&nbsp;"SWLS01-Live Life Over Change Nothing"</li><li class="codelist-item">•&nbsp;"SWLS01-My Life Conditions are Excellent"</li><li class="codelist-item">•&nbsp;"SWLS01-My Life is Close to Ideal"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSSL.IT.QSSL.QSCAT"></a>QSCAT</td><td>Category of Question</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.QSCAT_SL">Category of Questionnaire for SWLS</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SWLS" = "Satisfaction With Life Scale Questionnaire"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=16">16</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.QSSL.IT.QSSL.QSORRES"></a>QSORRES</td><td>Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">26</td><td><a href="#CL.CL.SWLSR">SWLS-Responses</a><p class="linebreakcell">
                  [7 Terms]
                </p></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=16">16</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.QSSL.IT.QSSL.QSSTRESC"></a>QSSTRESC</td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">1</td><td><a href="#CL.CL.SWLSR_S">SWLS-Responses Standardized</a><p class="linebreakcell">
                  [7 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=16">16</a><span class="external-link-gif"></span> ]</p><div class="method-code">If QSORRES="Strongly disagree" then 1
If QSORRES="Disagree" then 2
If QSORRES="Slightly disagree" then 3
If QSORRES="Neither agree nor disagree" then 4
If QSORRES="Slightly agree" then 5
If QSORRES="Agree" then 6
If QSORRES="Strongly agree" then 7</div></td></tr><tr class="tableroweven"><td><a id="IG.QSSL.IT.QSSL.QSSTRESN"></a>QSSTRESN</td><td>Numeric Finding in Standard Units</td><td class="datatype">integer</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=16">16</a><span class="external-link-gif"></span> ]</p><div class="method-code">If QSSTRESC is numeric then QSSTRESN=QSSTRESC in numeric format, else null.</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSSL.IT.QSSL.QSLOBXFL"></a>QSLOBXFL</td><td>Last Observation Before Exposure Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.</div></td></tr><tr class="tableroweven"><td><a id="IG.QSSL.IT.QSSL.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSSL.IT.QSSL.VISIT"></a>VISIT</td><td>Visit Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSSL.IT.QSSL.EPOCH"></a>EPOCH</td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.QSSL.IT.QSSL.QSDTC"></a>QSDTC</td><td>Date/Time of Finding</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.QSSL.IT.QSSL.QSDY"></a>QSDY</td><td>Study Day of Finding</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.RS"></a><div class="containerbox"><h1 class="invisible">Disease Response and Clin Classification (RS) </h1><table summary="ItemGroup IG.IG.RS"><caption><span>RS (Disease Response and Clin Classification) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="rs.xpt">rs.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.RS.IT.RS.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.RS.IT.RS.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_RS">SDTM Domain Abbreviation, subset used for Disease Response and Clin Classification</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"RS" = "Disease Response and Clin Classification"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.RS.IT.RS.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.RS.IT.RS.RSSEQ"></a>RSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.RS.IT.RS.RSTESTCD"></a>RSTESTCD</td><td></td><td>Assessment Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><a href="#CL.CL.HAMD17C">Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Code</a><p class="linebreakcell">
                  [19 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.RS.IT.RS.RSTEST"></a>RSTEST</td><td></td><td>Assessment Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">37</td><td><a href="#CL.CL.HAMD17T">Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Name</a><p class="linebreakcell">
                  [19 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.RS.IT.RS.RSCAT"></a>RSCAT</td><td></td><td>Category for Assessment</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.RSCAT">Category of Clinical Classification, subset to be used for RSCAT</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"HAMD 17" = "Hamilton Depression Rating Scale 17 Item Clinical Classification"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td>RSORRES<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.RS.IT.RS.RSORRES">VLM</a></span></td><td></td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">198</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD101" (HAMD1-Depressed Mood)</td><td>HAMD-17 Question 1</td><td class="datatype">text</td><td class="role"></td><td class="number">111</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD101">Hamilton Depression Rating Scale - 17 Item - Question 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Absent."</li><li class="codelist-item">•&nbsp;"These feeling states indicated only on questioning."</li><li class="codelist-item">•&nbsp;"These feeling states spontaneously reported verbally."</li><li class="codelist-item">•&nbsp;"Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep."</li><li class="codelist-item">•&nbsp;"Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD102" (HAMD1-Feelings of Guilt)</td><td>HAMD-17 Question 2</td><td class="datatype">text</td><td class="role"></td><td class="number">93</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD102">Hamilton Depression Rating Scale - 17 Item - Question 2</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Absent."</li><li class="codelist-item">•&nbsp;"Self reproach, feels he/she has let people down."</li><li class="codelist-item">•&nbsp;"Ideas of guilt or rumination over past errors or sinful deeds."</li><li class="codelist-item">•&nbsp;"Present illness is a punishment. Delusions of guilt."</li><li class="codelist-item">•&nbsp;"Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD103" (HAMD1-Suicide)</td><td>HAMD-17 Question 3</td><td class="datatype">text</td><td class="role"></td><td class="number">66</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD103">Hamilton Depression Rating Scale - 17 Item - Question 3</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Absent."</li><li class="codelist-item">•&nbsp;"Feels life is not worth living."</li><li class="codelist-item">•&nbsp;"Wishes he/she were dead or any thoughts of possible death to self."</li><li class="codelist-item">•&nbsp;"Ideas or gestures of suicide."</li><li class="codelist-item">•&nbsp;"Attempts at suicide (any serious attempt rate 4)."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD104" (HAMD1-Insomnia Early - Early Night)</td><td>HAMD-17 Question 4</td><td class="datatype">text</td><td class="role"></td><td class="number">74</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD104">Hamilton Depression Rating Scale - 17 Item - Question 4</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"No difficulty falling asleep."</li><li class="codelist-item">•&nbsp;"Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour"</li><li class="codelist-item">•&nbsp;"Complains of nightly difficulty falling asleep."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD105" (HAMD1-Insomnia Middle - Middle Night)</td><td>HAMD-17 Question 5</td><td class="datatype">text</td><td class="role"></td><td class="number">90</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD105">Hamilton Depression Rating Scale - 17 Item - Question 5</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"No difficulty."</li><li class="codelist-item">•&nbsp;"Patient complains of being restless and disturbed during the night."</li><li class="codelist-item">•&nbsp;"Waking during the night - any getting out of bed rates 2 (except for purposes of voiding)."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD106" (HAMD1-Insomnia Early Hours - Morning)</td><td>HAMD-17 Question 6</td><td class="datatype">text</td><td class="role"></td><td class="number">60</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD106">Hamilton Depression Rating Scale - 17 Item - Question 6</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"No difficulty."</li><li class="codelist-item">•&nbsp;"Waking in early hours of the morning but goes back to sleep."</li><li class="codelist-item">•&nbsp;"Unable to fall asleep again if he/she gets out of bed."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD107" (HAMD1-Work and Activities)</td><td>HAMD-17 Question 7</td><td class="datatype">text</td><td class="role"></td><td class="number">198</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD107">Hamilton Depression Rating Scale - 17 Item - Question 7</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"No difficulty."</li><li class="codelist-item">•&nbsp;"Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies."</li><li class="codelist-item">•&nbsp;"Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities)."</li><li class="codelist-item">•&nbsp;"Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores."</li><li class="codelist-item">•&nbsp;"Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD108" (HAMD1-Retardation)</td><td>HAMD-17 Question 8</td><td class="datatype">text</td><td class="role"></td><td class="number">41</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD108">Hamilton Depression Rating Scale - 17 Item - Question 8</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Normal speech and thought."</li><li class="codelist-item">•&nbsp;"Slight retardation during the interview."</li><li class="codelist-item">•&nbsp;"Obvious retardation during the interview."</li><li class="codelist-item">•&nbsp;"Interview difficult."</li><li class="codelist-item">•&nbsp;"Complete stupor."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD109" (HAMD1-Agitation)</td><td>HAMD-17 Question 9</td><td class="datatype">text</td><td class="role"></td><td class="number">57</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD109">Hamilton Depression Rating Scale - 17 Item - Question 9</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"None."</li><li class="codelist-item">•&nbsp;"Fidgetiness."</li><li class="codelist-item">•&nbsp;"Playing with hands, hair, etc."</li><li class="codelist-item">•&nbsp;"Moving about, cannot sit still."</li><li class="codelist-item">•&nbsp;"Hand wringing, nail biting, hair-pulling, biting of lips."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD110" (HAMD1-Anxiety Psychic)</td><td>HAMD-17 Question 10</td><td class="datatype">text</td><td class="role"></td><td class="number">49</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD110">Hamilton Depression Rating Scale - 17 Item - Question 10</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"No difficulty."</li><li class="codelist-item">•&nbsp;"Subjective tension and irritability."</li><li class="codelist-item">•&nbsp;"Worrying about minor matters."</li><li class="codelist-item">•&nbsp;"Apprehensive attitude apparent in face or speech."</li><li class="codelist-item">•&nbsp;"Fears expressed without questioning."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD111" (HAMD1-Anxiety Somatic)</td><td>HAMD-17 Question 11</td><td class="datatype">text</td><td class="role"></td><td class="number">15</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD111">Hamilton Depression Rating Scale - 17 Item - Question 11</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Absent."</li><li class="codelist-item">•&nbsp;"Mild."</li><li class="codelist-item">•&nbsp;"Moderate."</li><li class="codelist-item">•&nbsp;"Severe."</li><li class="codelist-item">•&nbsp;"Incapacitating."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD112" (HAMD1-Somatic Symptoms GI)</td><td>HAMD-17 Question 12</td><td class="datatype">text</td><td class="role"></td><td class="number">141</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD112">Hamilton Depression Rating Scale - 17 Item - Question 12</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"None."</li><li class="codelist-item">•&nbsp;"Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen."</li><li class="codelist-item">•&nbsp;"Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD113" (HAMD1-General Somatic Symptoms)</td><td>HAMD-17 Question 13</td><td class="datatype">text</td><td class="role"></td><td class="number">102</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD113">Hamilton Depression Rating Scale - 17 Item - Question 13</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"None."</li><li class="codelist-item">•&nbsp;"Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability."</li><li class="codelist-item">•&nbsp;"Any clear-cut symptom rates 2."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD114" (HAMD1-Genital Symptoms)</td><td>HAMD-17 Question 14</td><td class="datatype">text</td><td class="role"></td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD114">Hamilton Depression Rating Scale - 17 Item - Question 14</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Absent."</li><li class="codelist-item">•&nbsp;"Mild."</li><li class="codelist-item">•&nbsp;"Severe."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD115" (HAMD1-Hypochondriasis)</td><td>HAMD-17 Question 15</td><td class="datatype">text</td><td class="role"></td><td class="number">44</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD115">Hamilton Depression Rating Scale - 17 Item - Question 15</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Not present."</li><li class="codelist-item">•&nbsp;"Self-absorption (bodily)."</li><li class="codelist-item">•&nbsp;"Preoccupation with health."</li><li class="codelist-item">•&nbsp;"Frequent complaints, requests for help, etc."</li><li class="codelist-item">•&nbsp;"Hypochondriacal delusions."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD116A" (HAMD1-Loss of WT According to Patient)</td><td>HAMD-17 Question 16A</td><td class="datatype">text</td><td class="role"></td><td class="number">53</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD116A">Hamilton Depression Rating Scale - 17 Item - Question 16A</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"No weight loss."</li><li class="codelist-item">•&nbsp;"Probable weight loss associated with present illness."</li><li class="codelist-item">•&nbsp;"Definite (according to patient) weight loss."</li><li class="codelist-item">•&nbsp;"Not assessed."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD116B" (HAMD1-Loss of WT According to WK Meas)</td><td>HAMD-17 Question 16B</td><td class="datatype">text</td><td class="role"></td><td class="number">42</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD116B">Hamilton Depression Rating Scale - 17 Item - Question 16B</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Less than 1 lb weight loss in week."</li><li class="codelist-item">•&nbsp;"Greater than 1 lb weight loss within week."</li><li class="codelist-item">•&nbsp;"Greater than 2 lb weight loss in week."</li><li class="codelist-item">•&nbsp;"Not assessed."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD117" (HAMD1-Insight)</td><td>HAMD-17 Question 17</td><td class="datatype">text</td><td class="role"></td><td class="number">100</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD117">Hamilton Depression Rating Scale - 17 Item - Question 17</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Acknowledges being depressed and ill."</li><li class="codelist-item">•&nbsp;"Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc."</li><li class="codelist-item">•&nbsp;"Denies being ill at all."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.RS.IT.RS.RSORRES"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD118" (HAMD1-Total Score)</td><td>HAMD-17 Question 18</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td>RSSTRESC<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.RS.IT.RS.RSSTRESC">VLM</a></span></td><td></td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">RSSTRESC is the corresponding numeric value of RSORRES according the values shown on the HAMD-17 CRF page.</div></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD101" (HAMD1-Depressed Mood)</td><td>HAMD-17 Question 1 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD101S">Hamilton Depression Rating Scale - 17 Item - Question 1 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Absent."</li><li class="codelist-item">•&nbsp;1 = "These feeling states indicated only on questioning."</li><li class="codelist-item">•&nbsp;2 = "These feeling states spontaneously reported verbally."</li><li class="codelist-item">•&nbsp;3 = "Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep."</li><li class="codelist-item">•&nbsp;4 = "Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD102" (HAMD1-Feelings of Guilt)</td><td>HAMD-17 Question 2 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD102S">Hamilton Depression Rating Scale - 17 Item - Question 2 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Absent."</li><li class="codelist-item">•&nbsp;1 = "Self reproach, feels he/she has let people down."</li><li class="codelist-item">•&nbsp;2 = "Ideas of guilt or rumination over past errors or sinful deeds."</li><li class="codelist-item">•&nbsp;3 = "Present illness is a punishment. Delusions of guilt."</li><li class="codelist-item">•&nbsp;4 = "Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD103" (HAMD1-Suicide)</td><td>HAMD-17 Question 3 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD103S">Hamilton Depression Rating Scale - 17 Item - Question 3 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Absent."</li><li class="codelist-item">•&nbsp;1 = "Feels life is not worth living."</li><li class="codelist-item">•&nbsp;2 = "Wishes he/she were dead or any thoughts of possible death to self."</li><li class="codelist-item">•&nbsp;3 = "Ideas or gestures of suicide."</li><li class="codelist-item">•&nbsp;4 = "Attempts at suicide (any serious attempt rate 4)."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD104" (HAMD1-Insomnia Early - Early Night)</td><td>HAMD-17 Question 4 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD104S">Hamilton Depression Rating Scale - 17 Item - Question 4 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "No difficulty falling asleep."</li><li class="codelist-item">•&nbsp;1 = "Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour"</li><li class="codelist-item">•&nbsp;2 = "Complains of nightly difficulty falling asleep."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD105" (HAMD1-Insomnia Middle - Middle Night)</td><td>HAMD-17 Question 5 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD105S">Hamilton Depression Rating Scale - 17 Item - Question 5 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "No difficulty."</li><li class="codelist-item">•&nbsp;1 = "Patient complains of being restless and disturbed during the night."</li><li class="codelist-item">•&nbsp;2 = "Waking during the night - any getting out of bed rates 2 (except for purposes of voiding)."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD106" (HAMD1-Insomnia Early Hours - Morning)</td><td>HAMD-17 Question 6 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD106S">Hamilton Depression Rating Scale - 17 Item - Question 6 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "No difficulty."</li><li class="codelist-item">•&nbsp;1 = "Waking in early hours of the morning but goes back to sleep."</li><li class="codelist-item">•&nbsp;2 = "Unable to fall asleep again if he/she gets out of bed."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD107" (HAMD1-Work and Activities)</td><td>HAMD-17 Question 7 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD107S">Hamilton Depression Rating Scale - 17 Item - Question 7 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "No difficulty."</li><li class="codelist-item">•&nbsp;1 = "Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies."</li><li class="codelist-item">•&nbsp;2 = "Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities)."</li><li class="codelist-item">•&nbsp;3 = "Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores."</li><li class="codelist-item">•&nbsp;4 = "Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD108" (HAMD1-Retardation)</td><td>HAMD-17 Question 8 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD108S">Hamilton Depression Rating Scale - 17 Item - Question 8 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Normal speech and thought."</li><li class="codelist-item">•&nbsp;1 = "Slight retardation during the interview."</li><li class="codelist-item">•&nbsp;2 = "Obvious retardation during the interview."</li><li class="codelist-item">•&nbsp;3 = "Interview difficult."</li><li class="codelist-item">•&nbsp;4 = "Complete stupor."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD109" (HAMD1-Agitation)</td><td>HAMD-17 Question 9 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD109S">Hamilton Depression Rating Scale - 17 Item - Question 9 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "None."</li><li class="codelist-item">•&nbsp;1 = "Fidgetiness."</li><li class="codelist-item">•&nbsp;2 = "Playing with hands, hair, etc."</li><li class="codelist-item">•&nbsp;3 = "Moving about, cannot sit still."</li><li class="codelist-item">•&nbsp;4 = "Hand wringing, nail biting, hair-pulling, biting of lips."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD110" (HAMD1-Anxiety Psychic)</td><td>HAMD-17 Question 10 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD110S">Hamilton Depression Rating Scale - 17 Item - Question 10 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "No difficulty."</li><li class="codelist-item">•&nbsp;1 = "Subjective tension and irritability."</li><li class="codelist-item">•&nbsp;2 = "Worrying about minor matters."</li><li class="codelist-item">•&nbsp;3 = "Apprehensive attitude apparent in face or speech."</li><li class="codelist-item">•&nbsp;4 = "Fears expressed without questioning."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD111" (HAMD1-Anxiety Somatic)</td><td>HAMD-17 Question 11 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD111S">Hamilton Depression Rating Scale - 17 Item - Question 11 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Absent."</li><li class="codelist-item">•&nbsp;1 = "Mild."</li><li class="codelist-item">•&nbsp;2 = "Moderate."</li><li class="codelist-item">•&nbsp;3 = "Severe."</li><li class="codelist-item">•&nbsp;4 = "Incapacitating."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD112" (HAMD1-Somatic Symptoms GI)</td><td>HAMD-17 Question 12 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD112S">Hamilton Depression Rating Scale - 17 Item - Question 12 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "None."</li><li class="codelist-item">•&nbsp;1 = "Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen."</li><li class="codelist-item">•&nbsp;2 = "Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD113" (HAMD1-General Somatic Symptoms)</td><td>HAMD-17 Question 13 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD113S">Hamilton Depression Rating Scale - 17 Item - Question 13 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "None."</li><li class="codelist-item">•&nbsp;1 = "Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability."</li><li class="codelist-item">•&nbsp;2 = "Any clear-cut symptom rates 2."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD114" (HAMD1-Genital Symptoms)</td><td>HAMD-17 Question 14 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD114S">Hamilton Depression Rating Scale - 17 Item - Question 14 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Absent."</li><li class="codelist-item">•&nbsp;1 = "Mild."</li><li class="codelist-item">•&nbsp;2 = "Severe."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD115" (HAMD1-Hypochondriasis)</td><td>HAMD-17 Question 15 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD115S">Hamilton Depression Rating Scale - 17 Item - Question 15 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Not present."</li><li class="codelist-item">•&nbsp;1 = "Self-absorption (bodily)."</li><li class="codelist-item">•&nbsp;2 = "Preoccupation with health."</li><li class="codelist-item">•&nbsp;3 = "Frequent complaints, requests for help, etc."</li><li class="codelist-item">•&nbsp;4 = "Hypochondriacal delusions."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD116A" (HAMD1-Loss of WT According to Patient)</td><td>HAMD-17 Question 16A Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD116AS">Hamilton Depression Rating Scale - 17 Item - Question 16A Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "No weight loss."</li><li class="codelist-item">•&nbsp;1 = "Probable weight loss associated with present illness."</li><li class="codelist-item">•&nbsp;2 = "Definite (according to patient) weight loss."</li><li class="codelist-item">•&nbsp;3 = "Not assessed."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD116B" (HAMD1-Loss of WT According to WK Meas)</td><td>HAMD-17 Question 16B Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD116BS">Hamilton Depression Rating Scale - 17 Item - Question 16B Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Less than 1 lb weight loss in week."</li><li class="codelist-item">•&nbsp;1 = "Greater than 1 lb weight loss within week."</li><li class="codelist-item">•&nbsp;2 = "Greater than 2 lb weight loss in week."</li><li class="codelist-item">•&nbsp;3 = "Not assessed."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD117" (HAMD1-Insight)</td><td>HAMD-17 Question 17 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.HAMD117S">Hamilton Depression Rating Scale - 17 Item - Question 17 Standardized</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Acknowledges being depressed and ill."</li><li class="codelist-item">•&nbsp;1 = "Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc."</li><li class="codelist-item">•&nbsp;2 = "Denies being ill at all."</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.RS.IT.RS.RSSTRESC"><td></td><td><a href="#IG.RS.IT.RS.RSTESTCD" title="Assessment Short Name">RSTESTCD</a> = "HAMD118" (HAMD1-Total Score)</td><td>HAMD-17 Question 18 Standardized</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.RS.IT.RS.RSSTRESN"></a>RSSTRESN</td><td></td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">integer</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code.</div></td></tr><tr class="tablerowodd"><td><a id="IG.RS.IT.RS.RSLOBXFL"></a>RSLOBXFL</td><td></td><td>Last Observation Before Exposure Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.</div></td></tr><tr class="tableroweven"><td><a id="IG.RS.IT.RS.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.RS.IT.RS.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.RS.IT.RS.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.RS.IT.RS.RSDTC"></a>RSDTC</td><td></td><td>Date/Time of Assessment</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.RS.IT.RS.RSDY"></a>RSDY</td><td></td><td>Study Day of Assessment</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr class="tablerowodd"><td><a id="IG.RS.IT.RS.RSEVLINT"></a>RSEVLINT</td><td></td><td>Evaluation Interval</td><td class="datatype">durationDatetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=19">19</a><span class="external-link-gif"></span> ]</p></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.VS"></a><div class="containerbox"><h1 class="invisible">Vital Signs (VS) </h1><table summary="ItemGroup IG.IG.VS"><caption><span>VS (Vital Signs) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="vs.xpt">vs.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.VS.IT.VS.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_VS">SDTM Domain Abbreviation, subset used for Vital Signs</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"VS" = "Vital Signs"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.VS.IT.VS.VSSEQ"></a>VSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.VSTESTCD"></a>VSTESTCD</td><td></td><td>Vital Signs Test Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">6</td><td><a href="#CL.CL.VSTESTCD">Vital Signs Test Code</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.VS.IT.VS.VSTEST"></a>VSTEST</td><td></td><td>Vital Signs Test Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">24</td><td><a href="#CL.CL.VSTEST">Vital Signs Test Name</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.VSPOS"></a>VSPOS</td><td></td><td>Vital Signs Position of Subject</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.POSITION_VS">Position, subset to be used for VSPOS</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"STANDING" = "Standing"</li><li class="codelist-item">•&nbsp;"SUPINE" = "Supine"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td>VSORRES<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.VS.IT.VS.VSORRES">VLM</a></span></td><td></td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSORRES"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> IN (<br><span class="linebreakcell">"DIABP" (Diastolic Blood Pressure), </span><br><span class="linebreakcell">"SYSBP" (Systolic Blood Pressure)</span><br>) </td><td>Blood Pressure</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSORRES"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "HEIGHT" (Height)</td><td>Height</td><td class="datatype">float</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSORRES"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "PULSE" (Pulse Rate)</td><td>Pulse Rate</td><td class="datatype">integer</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSORRES"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "TEMP" (Temperature)</td><td>Temperature</td><td class="datatype">float</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSORRES"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "WEIGHT" (Weight)</td><td>Weight</td><td class="datatype">float</td><td class="role"></td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td>VSORRESU<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.VS.IT.VS.VSORRESU">VLM</a></span></td><td></td><td>Original Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">9</td><td></td><td></td></tr><tr class="vlm tablerowodd IG.VS.IT.VS.VSORRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> IN (<br><span class="linebreakcell">"DIABP" (Diastolic Blood Pressure), </span><br><span class="linebreakcell">"SYSBP" (Systolic Blood Pressure)</span><br>) </td><td>Blood Pressure Units</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_BP">Units for Vital Signs Results, subset for Blood Pressure</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmHg" = "Millimeter of Mercury"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.VS.IT.VS.VSORRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "HEIGHT" (Height)</td><td>Height Units</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_HEIGHT">Units for Vital Signs Results, subset for Height</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"in" = "Inch"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.VS.IT.VS.VSORRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "PULSE" (Pulse Rate)</td><td>Pulse Rate Units</td><td class="datatype">text</td><td class="role"></td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_PULSE">Units for Vital Signs Results, subset for Pulse</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"beats/min" = "Beats per Minute"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.VS.IT.VS.VSORRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "TEMP" (Temperature)</td><td>Temperature Units</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_TEMP">Units for Vital Signs Results, subset for Temperature</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Degree Fahrenheit"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tablerowodd IG.VS.IT.VS.VSORRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "WEIGHT" (Weight)</td><td>Weight Units</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_WT">Units for Vital Signs Results, subset for Weight</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LB" = "Pound"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.VS.IT.VS.VSSTRESC"></a>VSSTRESC</td><td></td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Data collected in conventional units (i.e. F, lbs, inches) is converted using standard conversion factors to standard units (C, kg, cm).</div></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.VSSTRESN"></a>VSSTRESN</td><td></td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">float</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code.</div></td></tr><tr class="tableroweven"><td>VSSTRESU<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.VS.IT.VS.VSSTRESU">VLM</a></span></td><td></td><td>Standard Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">9</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSSTRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> IN (<br><span class="linebreakcell">"DIABP" (Diastolic Blood Pressure), </span><br><span class="linebreakcell">"SYSBP" (Systolic Blood Pressure)</span><br>) </td><td>Blood Pressure Units Std</td><td class="datatype">text</td><td class="role"></td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_BP_STD">Units for Vital Signs Results, subset for Blood Pressure Std</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"mmHg" = "Millimeter of Mercury"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSSTRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "HEIGHT" (Height)</td><td>Height Units Std</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_HEIGHT_STD">Units for Vital Signs Results, subset for Height Std</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"cm" = "Centimeter"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSSTRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "PULSE" (Pulse Rate)</td><td>Pulse Rate Units Std</td><td class="datatype">text</td><td class="role"></td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_PULSE_STD">Units for Vital Signs Results, subset for Pulse Std</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"beats/min" = "Beats per Minute"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSSTRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "TEMP" (Temperature)</td><td>Temperature Units Std</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_TEMP_STD">Units for Vital Signs Results, subset for Temperature Std</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"C" = "Degree Celsius"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.VS.IT.VS.VSSTRESU"><td></td><td><a href="#IG.VS.IT.VS.VSTESTCD" title="Vital Signs Test Short Name">VSTESTCD</a> = "WEIGHT" (Weight)</td><td>Weight Units Std</td><td class="datatype">text</td><td class="role"></td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.VS_UNIT_WT_STD">Units for Vital Signs Results, subset for Weight Std</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"kg" = "Kilogram"</li></ul></td><td></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.VSSTAT"></a>VSSTAT<span class="nodata">[No Data]</span></td><td></td><td>Completion Status</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ND">Not Done</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"NOT DONE" = "Not Done"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">All vital signs were performed as expected, so VSSTAT was never populated. The variable is included as it was possible to populate it in this study.</p></td></tr><tr class="tableroweven"><td><a id="IG.VS.IT.VS.VSLOC"></a>VSLOC</td><td></td><td>Location of Vital Signs Measurement</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">11</td><td><span class="linebreakcell"><a href="#CL.CL.LOC_VS">Anatomical Location</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"EAR" = "Ear"</li><li class="codelist-item">•&nbsp;"ORAL CAVITY" = "Oral Cavity"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.VSLOBXFL"></a>VSLOBXFL</td><td></td><td>Last Observation Before Exposure Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.</div></td></tr><tr class="tableroweven"><td><a id="IG.VS.IT.VS.VSREPNUM"></a>VSREPNUM</td><td></td><td>Repetition Number</td><td class="datatype">integer</td><td class="role">Record Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.VS.IT.VS.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.VS.IT.VS.VSDTC"></a>VSDTC</td><td></td><td>Date/Time of Measurements</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=8">8</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=9">9</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=10">10</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=11">11</a><span class="external-link-gif"></span> <a class="external" href="acrf.pdf#page=12">12</a><span class="external-link-gif"></span>    <a class="external" href="acrf.pdf#page=13">13</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.VS.IT.VS.VSDY"></a>VSDY</td><td></td><td>Study Day of Vital Signs</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.FA"></a><div class="containerbox"><h1 class="invisible">Findings About Events or Interventions (FA) </h1><table summary="ItemGroup IG.IG.FA"><caption><span>FA (Findings About Events or Interventions) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="fa.xpt">fa.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.FA.IT.FA.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.FA.IT.FA.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_FA">SDTM Domain Abbreviation, subset used for Findings About Events or Interventions</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"FA" = "Findings About Events or Interventions"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.FA.IT.FA.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.FA.IT.FA.FASEQ"></a>FASEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr class="tablerowodd"><td><a id="IG.FA.IT.FA.FALNKGRP"></a>FALNKGRP</td><td></td><td>Link Group ID</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.FA.IT.FA.FATESTCD"></a>FATESTCD</td><td></td><td>Findings About Test Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.FATESTCD">Findings About Adverse Events Test Code</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"OCCUR" = "Occurrence Indicator"</li><li class="codelist-item">•&nbsp;"SEV" = "Severity/Intensity"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.FA.IT.FA.FATEST"></a>FATEST</td><td></td><td>Findings About Test Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.FATEST">Findings About Adverse Events Test Name</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Occurrence Indicator"</li><li class="codelist-item">•&nbsp;"Severity/Intensity"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.FA.IT.FA.FAOBJ"></a>FAOBJ</td><td></td><td>Object of the Observation</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">10</td><td><span class="linebreakcell"><a href="#CL.CL.FAOBJ">FA Object</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ERYTHEMA" = "Erythema"</li><li class="codelist-item">•&nbsp;"PAIN" = "Pain"</li><li class="codelist-item">•&nbsp;"INDURATION" = "Induration"</li><li class="codelist-item">•&nbsp;"PRURITUS" = "Pruritus"</li><li class="codelist-item">•&nbsp;"EDEMA" = "Edema"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=24">24</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.FA.IT.FA.FACAT"></a>FACAT</td><td></td><td>Category for Findings About</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">23</td><td><span class="linebreakcell"><a href="#CL.CL.FACAT">FA Category</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"INJECTION SITE REACTION" = "Injection Site Reaction"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=24">24</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td>FAORRES<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.FA.IT.FA.FAORRES">VLM</a></span></td><td></td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=24">24</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.FA.IT.FA.FAORRES"><td></td><td><a href="#IG.FA.IT.FA.FATESTCD" title="Findings About Test Short Name">FATESTCD</a> = "SEV" (Severity/Intensity)</td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.FASEV">Severity</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"MILD" = "Mild"</li><li class="codelist-item">•&nbsp;"MODERATE" = "Moderate"</li><li class="codelist-item">•&nbsp;"SEVERE" = "Severe"</li></ul></td><td></td></tr><tr class="vlm tableroweven IG.FA.IT.FA.FAORRES"><td></td><td><a href="#IG.FA.IT.FA.FATESTCD" title="Findings About Test Short Name">FATESTCD</a> = "OCCUR" (Occurrence Indicator)</td><td>Result or Finding in Original Units</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.FAOCCUR">Occurrence</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td></td></tr><tr class="tablerowodd"><td>FASTRESC<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.FA.IT.FA.FASTRESC">VLM</a></span></td><td></td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: FAORRES</div></td></tr><tr class="vlm tablerowodd IG.FA.IT.FA.FASTRESC"><td></td><td><a href="#IG.FA.IT.FA.FATESTCD" title="Findings About Test Short Name">FATESTCD</a> = "SEV" (Severity/Intensity)</td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role"></td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.FASEV">Severity</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"MILD" = "Mild"</li><li class="codelist-item">•&nbsp;"MODERATE" = "Moderate"</li><li class="codelist-item">•&nbsp;"SEVERE" = "Severe"</li></ul></td><td></td></tr><tr class="vlm tablerowodd IG.FA.IT.FA.FASTRESC"><td></td><td><a href="#IG.FA.IT.FA.FATESTCD" title="Findings About Test Short Name">FATESTCD</a> = "OCCUR" (Occurrence Indicator)</td><td>Character Result/Finding in Std Format</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.FAOCCUR">Occurrence</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td></td></tr><tr class="tableroweven"><td><a id="IG.FA.IT.FA.FALOC"></a>FALOC</td><td></td><td>Location of the Finding About</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">3</td><td><span class="linebreakcell"><a href="#CL.CL.LOC">Location</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ARM"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.FA.IT.FA.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">All values are null as the findings are not visit based. The variable is Expected and so is included.</p></td></tr><tr class="tableroweven"><td><a id="IG.FA.IT.FA.EPOCH"></a>EPOCH</td><td></td><td>Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td><span class="linebreakcell"><a href="#CL.CL.EPOCH">Epoch</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"SCREENING" = "Screening"</li><li class="codelist-item">•&nbsp;"TREATMENT" = "Treatment"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.FA.IT.FA.FADTC"></a>FADTC</td><td></td><td>Date/Time of Collection</td><td class="datatype">date</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=23">23</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tableroweven"><td><a id="IG.FA.IT.FA.FADY"></a>FADY</td><td></td><td>Study Day of Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.RELREC"></a><div class="containerbox"><h1 class="invisible">Related Records (RELREC) </h1><table summary="ItemGroup IG.IG.RELREC"><caption><span>RELREC (Related Records) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="relrec.xpt">relrec.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.RELREC.IT.RELREC.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.RELREC.IT.RELREC.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.RDOMAIN_RELREC">SDTM Domain Abbreviation, subset used for RELREC</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AE" = "Adverse Events"</li><li class="codelist-item">•&nbsp;"DS" = "Disposition"</li><li class="codelist-item">•&nbsp;"DD" = "Death Details"</li><li class="codelist-item">•&nbsp;"FA" = "Findings About Events or Interventions"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.RELREC.IT.RELREC.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.RELREC.IT.RELREC.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.RELREC.IT.RELREC.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.RELREC.IT.RELREC.RELTYPE"></a>RELTYPE</td><td>Relationship Type</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.RELTYPE">Relationship Type</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"MANY" = "Many"</li><li class="codelist-item">•&nbsp;"ONE" = "One"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.RELREC.IT.RELREC.RELID"></a>RELID</td><td>Relationship Identifier</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPDM"></a><div class="containerbox"><h1 class="invisible">Supplemental Qualifiers for DM (SUPPDM) </h1><table summary="ItemGroup IG.IG.SUPPDM"><caption><span>SUPPDM (Supplemental Qualifiers for DM, Demographics) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="suppdm.xpt">suppdm.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.DM">DM</a> (Demographics)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPDM.IT.SUPPDM.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPDM.IT.SUPPDM.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_DM">SDTM Domain Abbreviation, subset used for Demographics</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DM" = "Demographics"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPDM.IT.SUPPDM.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPDM.IT.SUPPDM.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPDM.IT.SUPPDM.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPDM.IT.SUPPDM.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">5</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPDM.IT.SUPPDM.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">40</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPDM.IT.SUPPDM.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">41</td><td></td><td></td></tr><tr class="vlm tableroweven IG.SUPPDM.IT.SUPPDM.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPDM.IT.SUPPDM.QNAM" title="Qualifier Variable Name">QNAM</a> = "RACE1"</div></td><td>Race 1</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">41</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native"</li><li class="codelist-item">•&nbsp;"ASIAN" = "Asian"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN" = "Black Or African American"</li><li class="codelist-item">•&nbsp;"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander"</li><li class="codelist-item">•&nbsp;"WHITE" = "White"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.SUPPDM.IT.SUPPDM.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPDM.IT.SUPPDM.QNAM" title="Qualifier Variable Name">QNAM</a> = "RACE2"</div></td><td>Race 2</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">41</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native"</li><li class="codelist-item">•&nbsp;"ASIAN" = "Asian"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN" = "Black Or African American"</li><li class="codelist-item">•&nbsp;"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander"</li><li class="codelist-item">•&nbsp;"WHITE" = "White"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.SUPPDM.IT.SUPPDM.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPDM.IT.SUPPDM.QNAM" title="Qualifier Variable Name">QNAM</a> = "RACE3"</div></td><td>Race 3</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">41</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native"</li><li class="codelist-item">•&nbsp;"ASIAN" = "Asian"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN" = "Black Or African American"</li><li class="codelist-item">•&nbsp;"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander"</li><li class="codelist-item">•&nbsp;"WHITE" = "White"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="vlm tableroweven IG.SUPPDM.IT.SUPPDM.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPDM.IT.SUPPDM.QNAM" title="Qualifier Variable Name">QNAM</a> = "RACE4"</div><span class="nodata">[No Data]</span></td><td>Race 4</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">41</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native"</li><li class="codelist-item">•&nbsp;"ASIAN" = "Asian"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN" = "Black Or African American"</li><li class="codelist-item">•&nbsp;"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander"</li><li class="codelist-item">•&nbsp;"WHITE" = "White"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">Since no subjects had more than 3 Races, RACE4 was not used.</p></td></tr><tr class="vlm tableroweven IG.SUPPDM.IT.SUPPDM.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPDM.IT.SUPPDM.QNAM" title="Qualifier Variable Name">QNAM</a> = "RACE5"</div><span class="nodata">[No Data]</span></td><td>Race 5</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">41</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE" = "American Indian Or Alaska Native"</li><li class="codelist-item">•&nbsp;"ASIAN" = "Asian"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN" = "Black Or African American"</li><li class="codelist-item">•&nbsp;"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "Native Hawaiian Or Other Pacific Islander"</li><li class="codelist-item">•&nbsp;"WHITE" = "White"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=5">5</a><span class="external-link-gif"></span> ]</p><p class="linebreakcell">Since no subjects had more than 3 Races, RACE5 was not used.</p></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPDM.IT.SUPPDM.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">13</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPDM.IT.SUPPDM.QEVAL"></a>QEVAL</td><td>Evaluator</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Since no collected data was subjective then QEVAL was not populated. It is an 'Expected' variable and so is included.</p></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPEC"></a><div class="containerbox"><h1 class="invisible">Supplemental Qualifiers for EC (SUPPEC) </h1><table summary="ItemGroup IG.IG.SUPPEC"><caption><span>SUPPEC (Supplemental Qualifiers for EC, Exposure as Collected) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="suppec.xpt">suppec.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.EC">EC</a> (Exposure as Collected)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPEC.IT.SUPPEC.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPEC.IT.SUPPEC.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">6</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPEC.IT.SUPPEC.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPEC.IT.SUPPEC.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPEC.IT.SUPPEC.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPEC.IT.SUPPEC.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPEC.IT.SUPPEC.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">40</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPEC.IT.SUPPEC.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td></td></tr><tr class="vlm tableroweven IG.SUPPEC.IT.SUPPEC.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPEC.IT.SUPPEC.QNAM" title="Qualifier Variable Name">QNAM</a> = "ECREASOC"</div></td><td>Reason for Occur Value</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=14">14</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPEC.IT.SUPPEC.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">13</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPEC.IT.SUPPEC.QEVAL"></a>QEVAL</td><td>Evaluator</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPNV"></a><div class="containerbox"><h1 class="invisible">Supplemental Qualifiers for NV (SUPPNV) </h1><table summary="ItemGroup IG.IG.SUPPNV"><caption><span>SUPPNV (Supplemental Qualifiers for NV, Nervous System Findings) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="nodata">[No Data]</span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.NV">NV</a> (Nervous System Findings)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPNV.IT.SUPPNV.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPNV.IT.SUPPNV.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_NV">SDTM Domain Abbreviation, subset used for Nervous System Findings</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"NV" = "Nervous Sysytem Findings"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPNV.IT.SUPPNV.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPNV.IT.SUPPNV.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPNV.IT.SUPPNV.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPNV.IT.SUPPNV.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPNV.IT.SUPPNV.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">40</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPNV.IT.SUPPNV.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">1</td><td></td><td></td></tr><tr class="vlm tableroweven IG.SUPPNV.IT.SUPPNV.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPNV.IT.SUPPNV.QNAM" title="Qualifier Variable Name">QNAM</a> = "NVCLSIG"</div></td><td>Clinically Significant</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_YONLY">No Yes Response, subset for variables with only "Y" or null values</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=20">20</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPNV.IT.SUPPNV.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">13</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPNV.IT.SUPPNV.QEVAL"></a>QEVAL</td><td>Evaluator</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPOE"></a><div class="containerbox"><h1 class="invisible">Supplemental Qualifiers for OE (SUPPOE) </h1><table summary="ItemGroup IG.IG.SUPPOE"><caption><span>SUPPOE (Supplemental Qualifiers for OE, Ophthalmic Examinations) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="nodata">[No Data]</span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.OE">OE</a> (Ophthalmic Examinations)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPOE.IT.SUPPOE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Protocol (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPOE.IT.SUPPOE.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_OE">SDTM Domain Abbreviation, subset used for Ophthalmic Examinations</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"OE" = "Ophthalmic Examinations"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPOE.IT.SUPPOE.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPOE.IT.SUPPOE.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPOE.IT.SUPPOE.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPOE.IT.SUPPOE.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPOE.IT.SUPPOE.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">40</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPOE.IT.SUPPOE.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">1</td><td></td><td></td></tr><tr class="vlm tableroweven IG.SUPPOE.IT.SUPPOE.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPOE.IT.SUPPOE.QNAM" title="Qualifier Variable Name">QNAM</a> = "OECLSIG"</div></td><td>Clinically Significant</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.NY_NY">No Yes Response, subset for variables with only "Y" or "N" val</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Collected (<span class="linebreakcell">Source: Investigator</span>)</div><p class="linebreakcell">Annotated CRF [<a class="external" href="acrf.pdf#page=21">21</a><span class="external-link-gif"></span> ]</p></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPOE.IT.SUPPOE.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">13</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPOE.IT.SUPPOE.QEVAL"></a>QEVAL</td><td>Evaluator</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.DI"></a><div class="containerbox"><h1 class="invisible">Device Identifiers (DI) </h1><table summary="ItemGroup IG.IG.DI"><caption><span>DI (Device Identifiers) -  <span class="standard-refeference">[STDTMIG 3.3]</span><span class="dataset">Location: <a class="external" href="di.xpt">di.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.DI.IT.DI.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DI.IT.DI.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.CL.DOMAIN_DI">SDTM Domain Abbreviation, subset used for Device Identifiers</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DI" = "Device Identifiers"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DI.IT.DI.SPDEVID"></a>SPDEVID</td><td>Sponsor Device Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DI.IT.DI.DISEQ"></a>DISEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Starts at "1" for first device identifier and increments by one for each DIPARM</div></td></tr><tr class="tablerowodd"><td><a id="IG.DI.IT.DI.DIPARMCD"></a>DIPARMCD</td><td>Device Identifier Element Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.DIPARMCD">Device Identifier Element Short Name</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DEVTYPE" = "Device Type"</li><li class="codelist-item">•&nbsp;"SERIAL" = "Serial Number"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tableroweven"><td><a id="IG.DI.IT.DI.DIPARM"></a>DIPARM</td><td>Device Identifier Element Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">13</td><td><span class="linebreakcell"><a href="#CL.CL.DIPARM">Device Identifier Element Name</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Device Type"</li><li class="codelist-item">•&nbsp;"Serial Number"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr><tr class="tablerowodd"><td><a id="IG.DI.IT.DI.DIVAL"></a>DIVAL</td><td>Device Identifier Element Value</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">200</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="decodelist"></a><div class="containerbox"><h1 class="header">CodeLists</h1><div class="codelist" id="CL.CL.ACN"><div class="codelist-caption">Action Taken with Study Treatment [<span class="nci">C66767</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Action Taken with Study Treatment"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DOSE INCREASED [<span class="nci">C49503</span>]</td><td class="codelist-item-decode">Dose Increased</td></tr><tr class="tableroweven"><td>DOSE NOT CHANGED [<span class="nci">C49504</span>]</td><td class="codelist-item-decode">Dose Not Changed</td></tr><tr class="tablerowodd"><td>DOSE REDUCED [<span class="nci">C49505</span>]</td><td class="codelist-item-decode">Dose Reduced</td></tr><tr class="tableroweven"><td>DRUG INTERRUPTED [<span class="nci">C49501</span>]</td><td class="codelist-item-decode">Drug Interrupted</td></tr><tr class="tablerowodd"><td>DRUG WITHDRAWN [<span class="nci">C49502</span>]</td><td class="codelist-item-decode">Drug Withdrawn</td></tr><tr class="tableroweven"><td>NOT APPLICABLE [<span class="nci">C48660</span>]</td><td class="codelist-item-decode">Not Applicable</td></tr><tr class="tablerowodd"><td>UNKNOWN [<span class="nci">C17998</span>]</td><td class="codelist-item-decode">Unknown</td></tr></table></div><div class="codelist" id="CL.CL.AEREL"><div class="codelist-caption">Relationship<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Relationship"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>RELATED</td><td class="codelist-item-decode">Related</td></tr><tr class="tableroweven"><td>UNLIKELY RELATED</td><td class="codelist-item-decode">Unlikely Related</td></tr><tr class="tablerowodd"><td>POSSIBLY RELATED</td><td class="codelist-item-decode">Possibly Related</td></tr><tr class="tableroweven"><td>NOT RELATED</td><td class="codelist-item-decode">Not Related</td></tr></table></div><div class="codelist" id="CL.CL.AESEV"><div class="codelist-caption">Severity/Intensity Scale for Adverse Events [<span class="nci">C66769</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Severity/Intensity Scale for Adverse Events"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>MILD [<span class="nci">C41338</span>]</td><td class="codelist-item-decode">Mild</td></tr><tr class="tableroweven"><td>MODERATE [<span class="nci">C41339</span>]</td><td class="codelist-item-decode">Moderate</td></tr><tr class="tablerowodd"><td>SEVERE [<span class="nci">C41340</span>]</td><td class="codelist-item-decode">Severe</td></tr></table></div><div class="codelist" id="CL.CL.AGEU_YEARS"><div class="codelist-caption">Age Unit in Years [<span class="nci">C66781</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Age Unit in Years"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>YEARS [<span class="nci">C29848</span>]</td><td class="codelist-item-decode">Years</td></tr></table></div><div class="codelist" id="CL.CL.ARM"><div class="codelist-caption">Arm<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Arm"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Placebo</td></tr><tr class="tableroweven"><td>Zanomaline Low Dose (54 mg)</td></tr><tr class="tablerowodd"><td>Zanomaline High Dose (81 mg)</td></tr></table></div><div class="codelist" id="CL.CL.ARMCD"><div class="codelist-caption">Arm Code<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Arm Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>PLACEBO</td><td class="codelist-item-decode">Placebo</td></tr><tr class="tableroweven"><td>ZAN_LOW</td><td class="codelist-item-decode">Zanomaline Low Dose (54 mg)</td></tr><tr class="tablerowodd"><td>ZAN_HIGH</td><td class="codelist-item-decode">Zanomaline High Dose (81 mg)</td></tr></table></div><div class="codelist" id="CL.CL.ARMNRS"><div class="codelist-caption">Arm Null Reason [<span class="nci">C142179</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Arm Null Reason"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SCREEN FAILURE [<span class="nci">C49628</span>]</td><td class="codelist-item-decode">Trial Screen Failure</td></tr></table></div><div class="codelist" id="CL.CL.AVL02TC"><div class="codelist-caption">Rey Auditory Verbal Learning Test Functional Test Code [<span class="nci">C123655</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Rey Auditory Verbal Learning Test Functional Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>AVL0201 [<span class="nci">C123683</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 1</td></tr><tr class="tableroweven"><td>AVL0202 [<span class="nci">C123684</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 2</td></tr><tr class="tablerowodd"><td>AVL0203 [<span class="nci">C123685</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 3</td></tr><tr class="tableroweven"><td>AVL0204 [<span class="nci">C123686</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 4</td></tr><tr class="tablerowodd"><td>AVL0205 [<span class="nci">C123687</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 5</td></tr><tr class="tableroweven"><td>AVL0206 [<span class="nci">C123688</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 6</td></tr><tr class="tablerowodd"><td>AVL0207 [<span class="nci">C123689</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 7</td></tr><tr class="tableroweven"><td>AVL0208 [<span class="nci">C123690</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 8</td></tr><tr class="tablerowodd"><td>AVL0209 [<span class="nci">C123691</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 9</td></tr><tr class="tableroweven"><td>AVL0210 [<span class="nci">C123692</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 10</td></tr><tr class="tablerowodd"><td>AVL0211 [<span class="nci">C123693</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 11</td></tr><tr class="tableroweven"><td>AVL0212 [<span class="nci">C123694</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 12</td></tr><tr class="tablerowodd"><td>AVL0213 [<span class="nci">C123695</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 13</td></tr><tr class="tableroweven"><td>AVL0214 [<span class="nci">C123696</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 14</td></tr><tr class="tablerowodd"><td>AVL0215 [<span class="nci">C123697</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Word 15</td></tr><tr class="tableroweven"><td>AVL0216 [<span class="nci">C123698</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Total</td></tr><tr class="tablerowodd"><td>AVL0217 [<span class="nci">C123699</span>]</td><td class="codelist-item-decode">AVLT-REY - List A Intrusions</td></tr><tr class="tableroweven"><td>AVL0218 [<span class="nci">C123700</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 1</td></tr><tr class="tablerowodd"><td>AVL0219 [<span class="nci">C123701</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 2</td></tr><tr class="tableroweven"><td>AVL0220 [<span class="nci">C123702</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 3</td></tr><tr class="tablerowodd"><td>AVL0221 [<span class="nci">C123703</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 4</td></tr><tr class="tableroweven"><td>AVL0222 [<span class="nci">C123704</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 5</td></tr><tr class="tablerowodd"><td>AVL0223 [<span class="nci">C123705</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 6</td></tr><tr class="tableroweven"><td>AVL0224 [<span class="nci">C123706</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 7</td></tr><tr class="tablerowodd"><td>AVL0225 [<span class="nci">C123707</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 8</td></tr><tr class="tableroweven"><td>AVL0226 [<span class="nci">C123708</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 9</td></tr><tr class="tablerowodd"><td>AVL0227 [<span class="nci">C123709</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 10</td></tr><tr class="tableroweven"><td>AVL0228 [<span class="nci">C123710</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 11</td></tr><tr class="tablerowodd"><td>AVL0229 [<span class="nci">C123711</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 12</td></tr><tr class="tableroweven"><td>AVL0230 [<span class="nci">C123712</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 13</td></tr><tr class="tablerowodd"><td>AVL0231 [<span class="nci">C123713</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 14</td></tr><tr class="tableroweven"><td>AVL0232 [<span class="nci">C123714</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Word 15</td></tr><tr class="tablerowodd"><td>AVL0233 [<span class="nci">C123715</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Total</td></tr><tr class="tableroweven"><td>AVL0234 [<span class="nci">C123716</span>]</td><td class="codelist-item-decode">AVLT-REY - List B Intrusions</td></tr></table></div><div class="codelist" id="CL.CL.AVL02TR"><div class="codelist-caption">Rey Auditory Verbal Learning Test Functional Test Response<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Rey Auditory Verbal Learning Test Functional Test Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>RECALLED</td><td class="codelist-item-decode">Recalled</td></tr><tr class="tableroweven"><td>NOT RECALLED</td><td class="codelist-item-decode">Not Recalled</td></tr></table></div><div class="codelist" id="CL.CL.AVL02TT"><div class="codelist-caption">Rey Auditory Verbal Learning Test Functional Test Name [<span class="nci">C123654</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Rey Auditory Verbal Learning Test Functional Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>AVL02- List B Total [<span class="nci">C123715</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Intrusions [<span class="nci">C123699</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List A Total [<span class="nci">C123698</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Word 1 [<span class="nci">C123683</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List A Word 10 [<span class="nci">C123692</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Word 11 [<span class="nci">C123693</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List A Word 12 [<span class="nci">C123694</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Word 13 [<span class="nci">C123695</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List A Word 14 [<span class="nci">C123696</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Word 15 [<span class="nci">C123697</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List A Word 2 [<span class="nci">C123684</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Word 3 [<span class="nci">C123685</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List A Word 4 [<span class="nci">C123686</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Word 5 [<span class="nci">C123687</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List A Word 6 [<span class="nci">C123688</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Word 7 [<span class="nci">C123689</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List A Word 8 [<span class="nci">C123690</span>]</td></tr><tr class="tableroweven"><td>AVL02-List A Word 9 [<span class="nci">C123691</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List B Intrusions [<span class="nci">C123716</span>]</td></tr><tr class="tableroweven"><td>AVL02-List B Word 1 [<span class="nci">C123700</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List B Word 10 [<span class="nci">C123709</span>]</td></tr><tr class="tableroweven"><td>AVL02-List B Word 11 [<span class="nci">C123710</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List B Word 12 [<span class="nci">C123711</span>]</td></tr><tr class="tableroweven"><td>AVL02-List B Word 13 [<span class="nci">C123712</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List B Word 14 [<span class="nci">C123713</span>]</td></tr><tr class="tableroweven"><td>AVL02-List B Word 15 [<span class="nci">C123714</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List B Word 2 [<span class="nci">C123701</span>]</td></tr><tr class="tableroweven"><td>AVL02-List B Word 3 [<span class="nci">C123702</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List B Word 4 [<span class="nci">C123703</span>]</td></tr><tr class="tableroweven"><td>AVL02-List B Word 5 [<span class="nci">C123704</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List B Word 6 [<span class="nci">C123705</span>]</td></tr><tr class="tableroweven"><td>AVL02-List B Word 7 [<span class="nci">C123706</span>]</td></tr><tr class="tablerowodd"><td>AVL02-List B Word 8 [<span class="nci">C123707</span>]</td></tr><tr class="tableroweven"><td>AVL02-List B Word 9 [<span class="nci">C123708</span>]</td></tr></table></div><div class="codelist" id="CL.CL.DDTEST"><div class="codelist-caption">Death Details Tests [<span class="nci">C116107</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Death Details Tests"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Primary Cause of Death [<span class="nci">C99531</span>]</td></tr></table></div><div class="codelist" id="CL.CL.DDTESTCD"><div class="codelist-caption">Death Details Test Codes [<span class="nci">C116108</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Death Details Test Codes"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>PRCDTH [<span class="nci">C99531</span>]</td><td class="codelist-item-decode">Primary Cause of Death</td></tr></table></div><div class="codelist" id="CL.CL.DIPARM"><div class="codelist-caption">Device Identifier Element Name [<span class="nci">C106480</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Device Identifier Element Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Device Type [<span class="nci">C53265</span>]</td></tr><tr class="tableroweven"><td>Serial Number [<span class="nci">C73518</span>]</td></tr></table></div><div class="codelist" id="CL.CL.DIPARMCD"><div class="codelist-caption">Device Identifier Element Short Name [<span class="nci">C106481</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Device Identifier Element Short Name"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DEVTYPE [<span class="nci">C53265</span>]</td><td class="codelist-item-decode">Device Type</td></tr><tr class="tableroweven"><td>SERIAL [<span class="nci">C73518</span>]</td><td class="codelist-item-decode">Serial Number</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_AE"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Adverse Events [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Adverse Events"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>AE [<span class="nci">C49562</span>]</td><td class="codelist-item-decode">Adverse Events</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_CM"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Concomitant Meds [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Concomitant Meds"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>CM [<span class="nci">C49568</span>]</td><td class="codelist-item-decode">Concomitant/Prior Medications</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_DD"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Death Diagnosis [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Death Diagnosis"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DD [<span class="nci">C95087</span>]</td><td class="codelist-item-decode">Death Details</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_DI"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Device Identifiers [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Device Identifiers"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DI [<span class="nci">C102618</span>]</td><td class="codelist-item-decode">Device Identifiers</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_DM"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Demographics [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Demographics"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DM [<span class="nci">C49572</span>]</td><td class="codelist-item-decode">Demographics</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_DS"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Disposition [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Disposition"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DS [<span class="nci">C49576</span>]</td><td class="codelist-item-decode">Disposition</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_EC"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Exposure as Collected [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Exposure as Collected"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>EC [<span class="nci">C117466</span>]</td><td class="codelist-item-decode">Exposure as Collected</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_EX"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Exposure [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Exposure"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>EX [<span class="nci">C49587</span>]</td><td class="codelist-item-decode">Exposure</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_FA"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Findings About Events or Interventions [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Findings About Events or Interventions"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>FA [<span class="nci">C85442</span>]</td><td class="codelist-item-decode">Findings About Events or Interventions</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_FT"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Functional Tests [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Functional Tests"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>FT [<span class="nci">C117756</span>]</td><td class="codelist-item-decode">Functional Tests</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_IE"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Inclusion/Exclusion [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Inclusion/Exclusion"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>IE [<span class="nci">C61536</span>]</td><td class="codelist-item-decode">Inclusion/Exclusion Criteria Not Met</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_LB"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Laboratory Data [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Laboratory Data"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>LB [<span class="nci">C49592</span>]</td><td class="codelist-item-decode">Laboratory Test Results</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_MH"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Medical History [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Medical History"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>MH [<span class="nci">C49603</span>]</td><td class="codelist-item-decode">Medical History</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_NV"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Nervous System Findings [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Nervous System Findings"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>NV [<span class="nci">C49592</span>]</td><td class="codelist-item-decode">Nervous Sysytem Findings</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_OE"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Ophthalmic Examinations [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Ophthalmic Examinations"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>OE [<span class="nci">C147180</span>]</td><td class="codelist-item-decode">Ophthalmic Examinations</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_QS"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Questionnaires [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Questionnaires"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>QS [<span class="nci">C49609</span>]</td><td class="codelist-item-decode">Questionnaires</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_RS"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Disease Response and Clin Classification [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Disease Response and Clin Classification"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>RS [<span class="nci">C107097</span>]</td><td class="codelist-item-decode">Disease Response and Clin Classification</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_SE"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Subject Element [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Subject Element"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SE [<span class="nci">C49616</span>]</td><td class="codelist-item-decode">Subject Elements</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_SV"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Subject Visits [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Subject Visits"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SV [<span class="nci">C49617</span>]</td><td class="codelist-item-decode">Subject Visits</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_TA"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Trial Arms [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Trial Arms"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>TA [<span class="nci">C49618</span>]</td><td class="codelist-item-decode">Trial Arms</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_TE"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Trial Elements [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Trial Elements"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>TE [<span class="nci">C49619</span>]</td><td class="codelist-item-decode">Trial Elements</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_TI"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Trial Inclusion/Exclusion Criteria [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Trial Inclusion/Exclusion Criteria"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>TI [<span class="nci">C49620</span>]</td><td class="codelist-item-decode">Trial Inclusion</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_TS"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Trial Summary [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Trial Summary"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>TS [<span class="nci">C53483</span>]</td><td class="codelist-item-decode">Trial Summary</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_TV"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Trial Visits [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Trial Visits"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>TV [<span class="nci">C49621</span>]</td><td class="codelist-item-decode">Trial Visits</td></tr></table></div><div class="codelist" id="CL.CL.DOMAIN_VS"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for Vital Signs [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for Vital Signs"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>VS [<span class="nci">C49622</span>]</td><td class="codelist-item-decode">Vital Signs</td></tr></table></div><div class="codelist" id="CL.CL.DSCAT"><div class="codelist-caption">Category for Disposition Event [<span class="nci">C74558</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Category for Disposition Event"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DISPOSITION EVENT [<span class="nci">C74590</span>]</td><td class="codelist-item-decode">Disposition Event</td></tr><tr class="tableroweven"><td>PROTOCOL MILESTONE [<span class="nci">C74588</span>]</td><td class="codelist-item-decode">Protocol Milestone</td></tr></table></div><div class="codelist" id="CL.CL.DSSCAT"><div class="codelist-caption">Subcategory for Disposition Event<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Subcategory for Disposition Event"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>STUDY TREATMENT</td><td class="codelist-item-decode">Study Treatment</td></tr><tr class="tableroweven"><td>STUDY PARTICIPATION</td><td class="codelist-item-decode">Study Participation</td></tr></table></div><div class="codelist" id="CL.CL.ELEMENT"><div class="codelist-caption">Element<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Element"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Screening</td></tr><tr class="tableroweven"><td>Placebo</td></tr><tr class="tablerowodd"><td>Zanomaline 54 mg</td></tr><tr class="tableroweven"><td>Zanomaline 54 mg Titration</td></tr><tr class="tablerowodd"><td>Zanomaline 81 mg</td></tr></table></div><div class="codelist" id="CL.CL.ENRTPT_CM_AE"><div class="codelist-caption">Relation to Reference Period, subset used for AE and CM. [<span class="nci">C66728</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Relation to Reference Period, subset used for AE and CM."><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ONGOING [<span class="nci">C53279</span>]</td><td class="codelist-item-decode">Ongoing</td></tr></table></div><div class="codelist" id="CL.CL.EPOCH"><div class="codelist-caption">Epoch [<span class="nci">C99079</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Epoch"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SCREENING [<span class="nci">C48262</span>]</td><td class="codelist-item-decode">Screening</td></tr><tr class="tableroweven"><td>TREATMENT [<span class="nci">C101526</span>]</td><td class="codelist-item-decode">Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ETCD"><div class="codelist-caption">Element Code<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Element Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>HIGH</td><td class="codelist-item-decode">Zanomaline 81 mg</td></tr><tr class="tableroweven"><td>LOW</td><td class="codelist-item-decode">Zanomaline 54 mg</td></tr><tr class="tablerowodd"><td>PLACEBO</td><td class="codelist-item-decode">Placebo</td></tr><tr class="tableroweven"><td>SCREEN</td><td class="codelist-item-decode">Screening</td></tr><tr class="tablerowodd"><td>TITRATE</td><td class="codelist-item-decode">Zanomaline 54 mg Titration</td></tr></table></div><div class="codelist" id="CL.CL.ETHNIC"><div class="codelist-caption">Ethnic Group Hispanic [<span class="nci">C66790</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Ethnic Group Hispanic"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>HISPANIC OR LATINO [<span class="nci">C17459</span>]</td><td class="codelist-item-decode">Hispanic or Latino</td></tr><tr class="tableroweven"><td>NOT HISPANIC OR LATINO [<span class="nci">C17459</span>]</td><td class="codelist-item-decode">Not Hispanic or Latino</td></tr></table></div><div class="codelist" id="CL.CL.EXTRT"><div class="codelist-caption">Study Treatment<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Study Treatment"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>PLACEBO</td><td class="codelist-item-decode">Placebo</td></tr><tr class="tableroweven"><td>ZANOMALINE</td><td class="codelist-item-decode">Zanomaline</td></tr></table></div><div class="codelist" id="CL.CL.FACAT"><div class="codelist-caption">FA Category<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - FA Category"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>INJECTION SITE REACTION</td><td class="codelist-item-decode">Injection Site Reaction</td></tr></table></div><div class="codelist" id="CL.CL.FAOBJ"><div class="codelist-caption">FA Object<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - FA Object"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ERYTHEMA</td><td class="codelist-item-decode">Erythema</td></tr><tr class="tableroweven"><td>PAIN</td><td class="codelist-item-decode">Pain</td></tr><tr class="tablerowodd"><td>INDURATION</td><td class="codelist-item-decode">Induration</td></tr><tr class="tableroweven"><td>PRURITUS</td><td class="codelist-item-decode">Pruritus</td></tr><tr class="tablerowodd"><td>EDEMA</td><td class="codelist-item-decode">Edema</td></tr></table></div><div class="codelist" id="CL.CL.FAOCCUR"><div class="codelist-caption">Occurrence [<span class="nci">C66742</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Occurrence"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>N [<span class="nci">C49487</span>]</td><td class="codelist-item-decode">No</td></tr><tr class="tableroweven"><td>Y [<span class="nci">C49488</span>]</td><td class="codelist-item-decode">Yes</td></tr></table></div><div class="codelist" id="CL.CL.FASEV"><div class="codelist-caption">Severity [<span class="nci">C66769</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Severity"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>MILD [<span class="nci">C41338</span>]</td><td class="codelist-item-decode">Mild</td></tr><tr class="tableroweven"><td>MODERATE [<span class="nci">C41339</span>]</td><td class="codelist-item-decode">Moderate</td></tr><tr class="tablerowodd"><td>SEVERE [<span class="nci">C41340</span>]</td><td class="codelist-item-decode">Severe</td></tr></table></div><div class="codelist" id="CL.CL.FATEST"><div class="codelist-caption">Findings About Adverse Events Test Name<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Findings About Adverse Events Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Occurrence Indicator</td></tr><tr class="tableroweven"><td>Severity/Intensity</td></tr></table></div><div class="codelist" id="CL.CL.FATESTCD"><div class="codelist-caption">Findings About Adverse Events Test Code<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Findings About Adverse Events Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>OCCUR</td><td class="codelist-item-decode">Occurrence Indicator</td></tr><tr class="tableroweven"><td>SEV</td><td class="codelist-item-decode">Severity/Intensity</td></tr></table></div><div class="codelist" id="CL.CL.FREQ_CM"><div class="codelist-caption">Frequency, subset used for CM [<span class="nci">C71113</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Frequency, subset used for CM"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>QD [<span class="nci">C25473</span>]</td><td class="codelist-item-decode">Daily</td></tr><tr class="tableroweven"><td>PRN [<span class="nci">C64499</span>]</td><td class="codelist-item-decode">As Needed</td></tr><tr class="tablerowodd"><td>BID [<span class="nci">C64496</span>]</td><td class="codelist-item-decode">Twice Daily</td></tr><tr class="tableroweven"><td>Q4H [<span class="nci">C64518</span>]</td><td class="codelist-item-decode">Every Four Hours</td></tr><tr class="tablerowodd"><td>QID [<span class="nci">C64530</span>]</td><td class="codelist-item-decode">Four Times Daily</td></tr><tr class="tableroweven"><td>Q6H [<span class="nci">C64520</span>]</td><td class="codelist-item-decode">Every Six Hours</td></tr></table></div><div class="codelist" id="CL.CL.FREQ_ECEX"><div class="codelist-caption">Frequency, subset used for EC and EX [<span class="nci">C71113</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Frequency, subset used for EC and EX"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>QD [<span class="nci">C25473</span>]</td><td class="codelist-item-decode">Daily</td></tr></table></div><div class="codelist" id="CL.CL.FRM_ECEX"><div class="codelist-caption">Dose Form, subset used for EC and EX [<span class="nci">C66726</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Dose Form, subset used for EC and EX"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>INJECTION [<span class="nci">C42946</span>]</td><td class="codelist-item-decode">Injectable Dosage Form</td></tr></table></div><div class="codelist" id="CL.CL.FTCAT"><div class="codelist-caption">Category of Functional Test, subset used for FTCAT [<span class="nci">C115304</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Category of Functional Test, subset used for FTCAT"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>AVLT-REY [<span class="nci">C123668</span>]</td><td class="codelist-item-decode">Rey Auditory Verbal Learning Functional Test</td></tr></table></div><div class="codelist" id="CL.CL.HAMD101"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 1<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 1"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Absent.</td></tr><tr class="tableroweven"><td>These feeling states indicated only on questioning.</td></tr><tr class="tablerowodd"><td>These feeling states spontaneously reported verbally.</td></tr><tr class="tableroweven"><td>Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep.</td></tr><tr class="tablerowodd"><td>Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD101S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 1 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 1 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Absent.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">These feeling states indicated only on questioning.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">These feeling states spontaneously reported verbally.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD102"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 2<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 2"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Absent.</td></tr><tr class="tableroweven"><td>Self reproach, feels he/she has let people down.</td></tr><tr class="tablerowodd"><td>Ideas of guilt or rumination over past errors or sinful deeds.</td></tr><tr class="tableroweven"><td>Present illness is a punishment. Delusions of guilt.</td></tr><tr class="tablerowodd"><td>Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD102S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 2 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 2 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Absent.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Self reproach, feels he/she has let people down.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Ideas of guilt or rumination over past errors or sinful deeds.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Present illness is a punishment. Delusions of guilt.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD103"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 3<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 3"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Absent.</td></tr><tr class="tableroweven"><td>Feels life is not worth living.</td></tr><tr class="tablerowodd"><td>Wishes he/she were dead or any thoughts of possible death to self.</td></tr><tr class="tableroweven"><td>Ideas or gestures of suicide.</td></tr><tr class="tablerowodd"><td>Attempts at suicide (any serious attempt rate 4).</td></tr></table></div><div class="codelist" id="CL.CL.HAMD103S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 3 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 3 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Absent.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Feels life is not worth living.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Wishes he/she were dead or any thoughts of possible death to self.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Ideas or gestures of suicide.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Attempts at suicide (any serious attempt rate 4).</td></tr></table></div><div class="codelist" id="CL.CL.HAMD104"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 4<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 4"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>No difficulty falling asleep.</td></tr><tr class="tableroweven"><td>Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour</td></tr><tr class="tablerowodd"><td>Complains of nightly difficulty falling asleep.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD104S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 4 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 4 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">No difficulty falling asleep.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Complains of nightly difficulty falling asleep.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD105"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 5<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 5"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>No difficulty.</td></tr><tr class="tableroweven"><td>Patient complains of being restless and disturbed during the night.</td></tr><tr class="tablerowodd"><td>Waking during the night - any getting out of bed rates 2 (except for purposes of voiding).</td></tr></table></div><div class="codelist" id="CL.CL.HAMD105S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 5 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 5 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">No difficulty.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Patient complains of being restless and disturbed during the night.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Waking during the night - any getting out of bed rates 2 (except for purposes of voiding).</td></tr></table></div><div class="codelist" id="CL.CL.HAMD106"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 6<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 6"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>No difficulty.</td></tr><tr class="tableroweven"><td>Waking in early hours of the morning but goes back to sleep.</td></tr><tr class="tablerowodd"><td>Unable to fall asleep again if he/she gets out of bed.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD106S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 6 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 6 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">No difficulty.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Waking in early hours of the morning but goes back to sleep.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Unable to fall asleep again if he/she gets out of bed.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD107"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 7<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 7"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>No difficulty.</td></tr><tr class="tableroweven"><td>Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies.</td></tr><tr class="tablerowodd"><td>Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities).</td></tr><tr class="tableroweven"><td>Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores.</td></tr><tr class="tablerowodd"><td>Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD107S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 7 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 7 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">No difficulty.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities).</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD108"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 8<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 8"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Normal speech and thought.</td></tr><tr class="tableroweven"><td>Slight retardation during the interview.</td></tr><tr class="tablerowodd"><td>Obvious retardation during the interview.</td></tr><tr class="tableroweven"><td>Interview difficult.</td></tr><tr class="tablerowodd"><td>Complete stupor.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD108S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 8 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 8 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Normal speech and thought.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Slight retardation during the interview.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Obvious retardation during the interview.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Interview difficult.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Complete stupor.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD109"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 9<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 9"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>None.</td></tr><tr class="tableroweven"><td>Fidgetiness.</td></tr><tr class="tablerowodd"><td>Playing with hands, hair, etc.</td></tr><tr class="tableroweven"><td>Moving about, cannot sit still.</td></tr><tr class="tablerowodd"><td>Hand wringing, nail biting, hair-pulling, biting of lips.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD109S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 9 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 9 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">None.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Fidgetiness.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Playing with hands, hair, etc.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Moving about, cannot sit still.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Hand wringing, nail biting, hair-pulling, biting of lips.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD110"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 10<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 10"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>No difficulty.</td></tr><tr class="tableroweven"><td>Subjective tension and irritability.</td></tr><tr class="tablerowodd"><td>Worrying about minor matters.</td></tr><tr class="tableroweven"><td>Apprehensive attitude apparent in face or speech.</td></tr><tr class="tablerowodd"><td>Fears expressed without questioning.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD110S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 10 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 10 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">No difficulty.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Subjective tension and irritability.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Worrying about minor matters.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Apprehensive attitude apparent in face or speech.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Fears expressed without questioning.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD111"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 11<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 11"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Absent.</td></tr><tr class="tableroweven"><td>Mild.</td></tr><tr class="tablerowodd"><td>Moderate.</td></tr><tr class="tableroweven"><td>Severe.</td></tr><tr class="tablerowodd"><td>Incapacitating.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD111S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 11 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 11 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Absent.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Mild.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Moderate.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Severe.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Incapacitating.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD112"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 12<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 12"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>None.</td></tr><tr class="tableroweven"><td>Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen.</td></tr><tr class="tablerowodd"><td>Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD112S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 12 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 12 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">None.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD113"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 13<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 13"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>None.</td></tr><tr class="tableroweven"><td>Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability.</td></tr><tr class="tablerowodd"><td>Any clear-cut symptom rates 2.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD113S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 13 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 13 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">None.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Any clear-cut symptom rates 2.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD114"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 14<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 14"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Absent.</td></tr><tr class="tableroweven"><td>Mild.</td></tr><tr class="tablerowodd"><td>Severe.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD114S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 14 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 14 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Absent.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Mild.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Severe.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD115"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 15<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 15"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Not present.</td></tr><tr class="tableroweven"><td>Self-absorption (bodily).</td></tr><tr class="tablerowodd"><td>Preoccupation with health.</td></tr><tr class="tableroweven"><td>Frequent complaints, requests for help, etc.</td></tr><tr class="tablerowodd"><td>Hypochondriacal delusions.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD115S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 15 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 15 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Not present.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Self-absorption (bodily).</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Preoccupation with health.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Frequent complaints, requests for help, etc.</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Hypochondriacal delusions.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD116A"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 16A<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 16A"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>No weight loss.</td></tr><tr class="tableroweven"><td>Probable weight loss associated with present illness.</td></tr><tr class="tablerowodd"><td>Definite (according to patient) weight loss.</td></tr><tr class="tableroweven"><td>Not assessed.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD116AS"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 16A Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 16A Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">No weight loss.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Probable weight loss associated with present illness.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Definite (according to patient) weight loss.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Not assessed.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD116B"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 16B<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 16B"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Less than 1 lb weight loss in week.</td></tr><tr class="tableroweven"><td>Greater than 1 lb weight loss within week.</td></tr><tr class="tablerowodd"><td>Greater than 2 lb weight loss in week.</td></tr><tr class="tableroweven"><td>Not assessed.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD116BS"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 16B Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 16B Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Less than 1 lb weight loss in week.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Greater than 1 lb weight loss within week.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Greater than 2 lb weight loss in week.</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Not assessed.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD117"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 17<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item - Question 17"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Acknowledges being depressed and ill.</td></tr><tr class="tableroweven"><td>Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc.</td></tr><tr class="tablerowodd"><td>Denies being ill at all.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD117S"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item - Question 17 Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item - Question 17 Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Acknowledges being depressed and ill.</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc.</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Denies being ill at all.</td></tr></table></div><div class="codelist" id="CL.CL.HAMD17C"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Code [<span class="nci">C100138</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>HAMD101 [<span class="nci">C100398</span>]</td><td class="codelist-item-decode">HAMD1-Depressed Mood</td></tr><tr class="tableroweven"><td>HAMD102 [<span class="nci">C100399</span>]</td><td class="codelist-item-decode">HAMD1-Feelings of Guilt</td></tr><tr class="tablerowodd"><td>HAMD103 [<span class="nci">C100400</span>]</td><td class="codelist-item-decode">HAMD1-Suicide</td></tr><tr class="tableroweven"><td>HAMD104 [<span class="nci">C100401</span>]</td><td class="codelist-item-decode">HAMD1-Insomnia Early - Early Night</td></tr><tr class="tablerowodd"><td>HAMD105 [<span class="nci">C100402</span>]</td><td class="codelist-item-decode">HAMD1-Insomnia Middle - Middle Night</td></tr><tr class="tableroweven"><td>HAMD106 [<span class="nci">C100403</span>]</td><td class="codelist-item-decode">HAMD1-Insomnia Early Hours - Morning</td></tr><tr class="tablerowodd"><td>HAMD107 [<span class="nci">C100404</span>]</td><td class="codelist-item-decode">HAMD1-Work and Activities</td></tr><tr class="tableroweven"><td>HAMD108 [<span class="nci">C100405</span>]</td><td class="codelist-item-decode">HAMD1-Retardation</td></tr><tr class="tablerowodd"><td>HAMD109 [<span class="nci">C100406</span>]</td><td class="codelist-item-decode">HAMD1-Agitation</td></tr><tr class="tableroweven"><td>HAMD110 [<span class="nci">C100407</span>]</td><td class="codelist-item-decode">HAMD1-Anxiety Psychic</td></tr><tr class="tablerowodd"><td>HAMD111 [<span class="nci">C100408</span>]</td><td class="codelist-item-decode">HAMD1-Anxiety Somatic</td></tr><tr class="tableroweven"><td>HAMD112 [<span class="nci">C100409</span>]</td><td class="codelist-item-decode">HAMD1-Somatic Symptoms GI</td></tr><tr class="tablerowodd"><td>HAMD113 [<span class="nci">C100410</span>]</td><td class="codelist-item-decode">HAMD1-General Somatic Symptoms</td></tr><tr class="tableroweven"><td>HAMD114 [<span class="nci">C100411</span>]</td><td class="codelist-item-decode">HAMD1-Genital Symptoms</td></tr><tr class="tablerowodd"><td>HAMD115 [<span class="nci">C100412</span>]</td><td class="codelist-item-decode">HAMD1-Hypochondriasis</td></tr><tr class="tableroweven"><td>HAMD116A [<span class="nci">C100413</span>]</td><td class="codelist-item-decode">HAMD1-Loss of WT According to Patient</td></tr><tr class="tablerowodd"><td>HAMD116B [<span class="nci">C100414</span>]</td><td class="codelist-item-decode">HAMD1-Loss of WT According to WK Meas</td></tr><tr class="tableroweven"><td>HAMD117 [<span class="nci">C100415</span>]</td><td class="codelist-item-decode">HAMD1-Insight</td></tr><tr class="tablerowodd"><td>HAMD118 [<span class="nci">C100416</span>]</td><td class="codelist-item-decode">HAMD1-Total Score</td></tr></table></div><div class="codelist" id="CL.CL.HAMD17T"><div class="codelist-caption">Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Name [<span class="nci">C100137</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Hamilton Depression Rating Scale - 17 Item Clinical Classification Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>HAMD1-Depressed Mood [<span class="nci">C100398</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Feelings of Guilt [<span class="nci">C100399</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-Suicide [<span class="nci">C100400</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Insomnia Early - Early Night [<span class="nci">C100401</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-Insomnia Middle - Middle Night [<span class="nci">C100402</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Insomnia Early Hours - Morning [<span class="nci">C100403</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-Work and Activities [<span class="nci">C100404</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Retardation [<span class="nci">C100405</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-Agitation [<span class="nci">C100406</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Anxiety Psychic [<span class="nci">C100407</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-Anxiety Somatic [<span class="nci">C100408</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Somatic Symptoms GI [<span class="nci">C100409</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-General Somatic Symptoms [<span class="nci">C100410</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Genital Symptoms [<span class="nci">C100411</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-Hypochondriasis [<span class="nci">C100412</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Loss of WT According to Patient [<span class="nci">C100413</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-Loss of WT According to WK Meas [<span class="nci">C100414</span>]</td></tr><tr class="tableroweven"><td>HAMD1-Insight [<span class="nci">C100415</span>]</td></tr><tr class="tablerowodd"><td>HAMD1-Total Score [<span class="nci">C100416</span>]</td></tr></table></div><div class="codelist" id="CL.CL.IECAT"><div class="codelist-caption">Category for Inclusion/Exclusion [<span class="nci">C66797</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Category for Inclusion/Exclusion"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>EXCLUSION [<span class="nci">C25370</span>]</td><td class="codelist-item-decode">Exclusion</td></tr><tr class="tableroweven"><td>INCLUSION [<span class="nci">C25532</span>]</td><td class="codelist-item-decode">Inclusion</td></tr></table></div><div class="codelist" id="CL.CL.IETEST"><div class="codelist-caption">Inclusion/Exclusion Criterion<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Inclusion/Exclusion Criterion"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Males and postmenopausal females at least 50 years of age.</td></tr><tr class="tableroweven"><td>Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines.</td></tr><tr class="tablerowodd"><td>MMSE score of 10 to 23.</td></tr><tr class="tableroweven"><td>Modified Hachinski Ischemic Scale score of &lt;= 4.</td></tr><tr class="tablerowodd"><td>CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. (See Protocol for incompatible findings.)</td></tr><tr class="tableroweven"><td>Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver.</td></tr><tr class="tablerowodd"><td>Geographic proximity to investigator's site that allows adequate follow-up.</td></tr><tr class="tableroweven"><td>Caregiver will monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home.</td></tr><tr class="tablerowodd"><td>Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of Zanomaline.</td></tr><tr class="tableroweven"><td>Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study.</td></tr><tr class="tablerowodd"><td>Serious illness which required hospitalization within 3 months of screening.</td></tr><tr class="tableroweven"><td>Diagnosis of serious neurological conditions (See Protocol)</td></tr><tr class="tablerowodd"><td>Diagnosis of serious neurological conditions (See Amendment 1)</td></tr><tr class="tableroweven"><td>Episode of depression meeting DSM-IV criteria within 3 months of screening.</td></tr><tr class="tablerowodd"><td>A history within the last 5 years of the following: a) Schizophrenia b) Bipolar Disease c) Ethanol or psychoactive drug abuse or dependence.</td></tr><tr class="tableroweven"><td>A history of syncope within the last 5 years.</td></tr><tr class="tablerowodd"><td>Evidence from ECG recording at screening of any of the following conditions: a) Left bundle branch block b) Bradycardia &lt;50 beats per minute c) Sinus pauses &gt;2 seconds (See Protocol for Remainder)</td></tr><tr class="tableroweven"><td>A history within the last 5 years of a serious cardiovascular disorder, including a) Clinically significant arrhythmia (See Protocol for Remainder)</td></tr><tr class="tablerowodd"><td>A history within the last 5 years of a serious gastrointestinal disorder, including a) Chronic peptic/duodenal/gastric/esophageal ulcer that are untreated or refractory to treatment(See Protocol)</td></tr><tr class="tableroweven"><td>A history within the last 5 years of a serious endocrine disorder, including a) Uncontrolled Insulin Dependent Diabetes Mellitus (IDDM) (See Protocol for other excluded disorders)</td></tr><tr class="tablerowodd"><td>A history within the last 5 years of a serious respiratory disorder, including a) Asthma with bronchospasm refractory to treatment b) Decompensated chronic obstructive pulmonary disease.</td></tr><tr class="tableroweven"><td>A history within the last 5 years of a serious genitourinary disorder, including a) Renal failure b) Uncontrolled urinary retention</td></tr><tr class="tablerowodd"><td>A history within the last 5 years of a serious rheumatologic disorder, including a) Lupus b) Temporal arteritis c) Severe rheumatoid arthritis</td></tr><tr class="tableroweven"><td>A known history of human immunodeficiency virus (HIV) within the last 5 years.</td></tr><tr class="tablerowodd"><td>A history within the last 5 years of a serious infectious disease including a) Neurosyphilis b) Meningitis c) Encephalitis</td></tr><tr class="tableroweven"><td>A history within the last 5 years of a primary or recurrent malignant disease (See Exceptions in Protocol).</td></tr><tr class="tablerowodd"><td>Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy).</td></tr><tr class="tableroweven"><td>Laboratory test values exceeding the Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, (See Protocol for Additional Analytes)</td></tr><tr class="tablerowodd"><td>Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests.</td></tr><tr class="tableroweven"><td>Positive syphilis screening with confirmatory testing.</td></tr><tr class="tablerowodd"><td>Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only).</td></tr><tr class="tableroweven"><td>Treatment with medications within 1 month prior to enrollment (See Protocol)</td></tr><tr class="tablerowodd"><td>Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active (See Amendment 1)</td></tr></table></div><div class="codelist" id="CL.CL.IETESTCD"><div class="codelist-caption">Incl/Excl Criterion Short Name<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Incl/Excl Criterion Short Name"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>INCL01</td><td class="codelist-item-decode">Males and postmenopausal females at least 50 years of age.</td></tr><tr class="tableroweven"><td>INCL02</td><td class="codelist-item-decode">Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines.</td></tr><tr class="tablerowodd"><td>INCL03</td><td class="codelist-item-decode">MMSE score of 10 to 23.</td></tr><tr class="tableroweven"><td>INCL04</td><td class="codelist-item-decode">Modified Hachinski Ischemic Scale score of &lt;= 4.</td></tr><tr class="tablerowodd"><td>INCL05</td><td class="codelist-item-decode">CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. (See Protocol for incompatible findings.)</td></tr><tr class="tableroweven"><td>INCL06</td><td class="codelist-item-decode">Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver.</td></tr><tr class="tablerowodd"><td>INCL07</td><td class="codelist-item-decode">Geographic proximity to investigator's site that allows adequate follow-up.</td></tr><tr class="tableroweven"><td>INCL08</td><td class="codelist-item-decode">Caregiver will monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home.</td></tr><tr class="tablerowodd"><td>EXCL09</td><td class="codelist-item-decode">Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of Zanomaline.</td></tr><tr class="tableroweven"><td>EXCL10</td><td class="codelist-item-decode">Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study.</td></tr><tr class="tablerowodd"><td>EXCL11</td><td class="codelist-item-decode">Serious illness which required hospitalization within 3 months of screening.</td></tr><tr class="tableroweven"><td>EXCL12</td><td class="codelist-item-decode">Diagnosis of serious neurological conditions</td></tr><tr class="tablerowodd"><td>EXCL13</td><td class="codelist-item-decode">Episode of depression meeting DSM-IV criteria within 3 months of screening.</td></tr><tr class="tableroweven"><td>EXCL14</td><td class="codelist-item-decode">A history within the last 5 years of the following: a) Schizophrenia b) Bipolar Disease c) Ethanol or psychoactive drug abuse or dependence.</td></tr><tr class="tablerowodd"><td>EXCL15</td><td class="codelist-item-decode">A history of syncope within the last 5 years.</td></tr><tr class="tableroweven"><td>EXCL16</td><td class="codelist-item-decode">Evidence from ECG recording at screening of any of the following conditions: a) Left bundle branch block b) Bradycardia &lt;50 beats per minute c) Sinus pauses &gt;2 seconds (See Protocol for Remainder)</td></tr><tr class="tablerowodd"><td>EXCL17</td><td class="codelist-item-decode">A history within the last 5 years of a serious cardiovascular disorder, including a) Clinically significant arrhythmia (See Protocol for Remainder)</td></tr><tr class="tableroweven"><td>EXCL18</td><td class="codelist-item-decode">A history within the last 5 years of a serious gastrointestinal disorder, including
a) Chronic peptic/duodenal/gastric/esophageal ulcer that are untreated or refractory to treatment(See Protocol)</td></tr><tr class="tablerowodd"><td>EXCL19</td><td class="codelist-item-decode">A history within the last 5 years of a serious endocrine disorder, including
a) Uncontrolled Insulin Dependent Diabetes Mellitus (IDDM) (See Protocol for other excluded disorders)</td></tr><tr class="tableroweven"><td>EXCL20</td><td class="codelist-item-decode">A history within the last 5 years of a serious respiratory disorder, including a) Asthma with bronchospasm refractory to treatment b) Decompensated chronic obstructive pulmonary disease.</td></tr><tr class="tablerowodd"><td>EXCL21</td><td class="codelist-item-decode">A history within the last 5 years of a serious genitourinary disorder, including a) Renal failure b) Uncontrolled urinary retention</td></tr><tr class="tableroweven"><td>EXCL22</td><td class="codelist-item-decode">A history within the last 5 years of a serious rheumatologic disorder, including a) Lupus b) Temporal arteritis c) Severe rheumatoid arthritis</td></tr><tr class="tablerowodd"><td>EXCL23</td><td class="codelist-item-decode">A known history of human immunodeficiency virus (HIV) within the last 5 years.</td></tr><tr class="tableroweven"><td>EXCL24</td><td class="codelist-item-decode">A history within the last 5 years of a serious infectious disease including a) Neurosyphilis b) Meningitis c) Encephalitis</td></tr><tr class="tablerowodd"><td>EXCL25</td><td class="codelist-item-decode">A history within the last 5 years of a primary or recurrent malignant disease (See Exceptions in Protocol).</td></tr><tr class="tableroweven"><td>EXCL26</td><td class="codelist-item-decode">Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy).</td></tr><tr class="tablerowodd"><td>EXCL27</td><td class="codelist-item-decode">Laboratory test values exceeding the Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, (See Protocol for Additional Analytes)</td></tr><tr class="tableroweven"><td>EXCL28</td><td class="codelist-item-decode">Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests.</td></tr><tr class="tablerowodd"><td>EXCL29</td><td class="codelist-item-decode">Positive syphilis screening with confirmatory testing.</td></tr><tr class="tableroweven"><td>EXCL30</td><td class="codelist-item-decode">Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only).</td></tr><tr class="tablerowodd"><td>EXCL31</td><td class="codelist-item-decode">Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active</td></tr><tr class="tableroweven"><td>EXCL12A</td><td class="codelist-item-decode">Diagnosis of serious neurological conditions (Amend 1)</td></tr><tr class="tablerowodd"><td>EXCL31A</td><td class="codelist-item-decode">Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active (Amend 1)</td></tr></table></div><div class="codelist" id="CL.CL.INTMODEL"><div class="codelist-caption">Intervention Model Response [<span class="nci">C99076</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Intervention Model Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>PARALLEL [<span class="nci">C82639</span>]</td><td class="codelist-item-decode">Parallel</td></tr></table></div><div class="codelist" id="CL.CL.INTTYPE"><div class="codelist-caption">Intervention Type Response [<span class="nci">C99078</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Intervention Type Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DRUG [<span class="nci">C1909</span>]</td><td class="codelist-item-decode">Drug</td></tr></table></div><div class="codelist" id="CL.CL.LAT_OE"><div class="codelist-caption">Laterality, subset to be used in OE [<span class="nci">C99073</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Laterality, subset to be used in OE"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>LEFT [<span class="nci">C25229</span>]</td><td class="codelist-item-decode">Left</td></tr><tr class="tableroweven"><td>RIGHT [<span class="nci">C25228</span>]</td><td class="codelist-item-decode">Right</td></tr></table></div><div class="codelist" id="CL.CL.LBCAT"><div class="codelist-caption">Laboratory Test Category<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Laboratory Test Category"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>CHEMISTRY</td><td class="codelist-item-decode">Chemistry</td></tr><tr class="tableroweven"><td>HEMATOLOGY</td><td class="codelist-item-decode">Hematology</td></tr><tr class="tablerowodd"><td>URINALYSIS</td><td class="codelist-item-decode">Urinalysis</td></tr><tr class="tableroweven"><td>OTHER</td><td class="codelist-item-decode">Other</td></tr></table></div><div class="codelist" id="CL.CL.LBTEST"><div class="codelist-caption">Laboratory Test Name [<span class="nci">C67154</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Laboratory Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Albumin [<span class="nci">C64431</span>]</td></tr><tr class="tableroweven"><td>Alkaline Phosphatase [<span class="nci">C64432</span>]</td></tr><tr class="tablerowodd"><td>Alanine Aminotransferase [<span class="nci">C64433</span>]</td></tr><tr class="tableroweven"><td>Anisocytes; Anisocytosis [<span class="nci">C74797</span>]</td></tr><tr class="tablerowodd"><td>Aspartate Aminotransferase [<span class="nci">C64467</span>]</td></tr><tr class="tableroweven"><td>Basophils [<span class="nci">C64470</span>]</td></tr><tr class="tablerowodd"><td>Bilirubin [<span class="nci">C38037</span>]</td></tr><tr class="tableroweven"><td>Calcium [<span class="nci">C64488</span>]</td></tr><tr class="tablerowodd"><td>Cholesterol [<span class="nci">C105586</span>]</td></tr><tr class="tableroweven"><td>Creatine Kinase [<span class="nci">C64489</span>]</td></tr><tr class="tablerowodd"><td>Chloride [<span class="nci">C64495</span>]</td></tr><tr class="tableroweven"><td>Color [<span class="nci">C64546</span>]</td></tr><tr class="tablerowodd"><td>Creatinine [<span class="nci">C64547</span>]</td></tr><tr class="tableroweven"><td>Eosinophils [<span class="nci">C64550</span>]</td></tr><tr class="tablerowodd"><td>Gamma Glutamyl Transferase [<span class="nci">C64847</span>]</td></tr><tr class="tableroweven"><td>Glucose [<span class="nci">C105585</span>]</td></tr><tr class="tablerowodd"><td>Hematocrit [<span class="nci">C64796</span>]</td></tr><tr class="tableroweven"><td>Hemoglobin [<span class="nci">C64848</span>]</td></tr><tr class="tablerowodd"><td>Potassium [<span class="nci">C64853</span>]</td></tr><tr class="tableroweven"><td>Ketones [<span class="nci">C64854</span>]</td></tr><tr class="tablerowodd"><td>Lymphocytes [<span class="nci">C51949</span>]</td></tr><tr class="tableroweven"><td>Macrocytes [<span class="nci">C64821</span>]</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular Hemoglobin [<span class="nci">C64797</span>]</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular HGB Concentration [<span class="nci">C64798</span>]</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular Volume [<span class="nci">C64799</span>]</td></tr><tr class="tableroweven"><td>Monocytes [<span class="nci">C64823</span>]</td></tr><tr class="tablerowodd"><td>pH [<span class="nci">C45997</span>]</td></tr><tr class="tableroweven"><td>Phosphate [<span class="nci">C64857</span>]</td></tr><tr class="tablerowodd"><td>Platelets [<span class="nci">C51951</span>]</td></tr><tr class="tableroweven"><td>Poikilocytes [<span class="nci">C79602</span>]</td></tr><tr class="tablerowodd"><td>Protein [<span class="nci">C64858</span>]</td></tr><tr class="tableroweven"><td>Erythrocytes [<span class="nci">C51946</span>]</td></tr><tr class="tablerowodd"><td>Sodium [<span class="nci">C64809</span>]</td></tr><tr class="tableroweven"><td>Specific Gravity [<span class="nci">C64832</span>]</td></tr><tr class="tablerowodd"><td>Thyrotropin [<span class="nci">C64813</span>]</td></tr><tr class="tableroweven"><td>Urate [<span class="nci">C64814</span>]</td></tr><tr class="tablerowodd"><td>Urea Nitrogen [<span class="nci">C125949</span>]</td></tr><tr class="tableroweven"><td>Urobilinogen [<span class="nci">C64816</span>]</td></tr><tr class="tablerowodd"><td>Vitamin B12 [<span class="nci">C64817</span>]</td></tr><tr class="tableroweven"><td>Leukocytes [<span class="nci">C51948</span>]</td></tr></table></div><div class="codelist" id="CL.CL.LBTESTCD"><div class="codelist-caption">Laboratory Test Code [<span class="nci">C65047</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Laboratory Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ALB [<span class="nci">C64431</span>]</td><td class="codelist-item-decode">Albumin Measurement</td></tr><tr class="tableroweven"><td>ALP [<span class="nci">C64432</span>]</td><td class="codelist-item-decode">Alkaline Phosphatase Measurement</td></tr><tr class="tablerowodd"><td>ALT [<span class="nci">C64433</span>]</td><td class="codelist-item-decode">Alanine Aminotransferase Measurement</td></tr><tr class="tableroweven"><td>ANISO [<span class="nci">C74797</span>]</td><td class="codelist-item-decode">Anisocyte Measurement</td></tr><tr class="tablerowodd"><td>AST [<span class="nci">C64467</span>]</td><td class="codelist-item-decode">Aspartate Aminotransferase Measurement</td></tr><tr class="tableroweven"><td>BASO [<span class="nci">C64470</span>]</td><td class="codelist-item-decode">Total Basophil Count</td></tr><tr class="tablerowodd"><td>BILI [<span class="nci">C38037</span>]</td><td class="codelist-item-decode">Total Bilirubin Measurement</td></tr><tr class="tableroweven"><td>CA [<span class="nci">C64488</span>]</td><td class="codelist-item-decode">Calcium Measurement</td></tr><tr class="tablerowodd"><td>CHOL [<span class="nci">C105586</span>]</td><td class="codelist-item-decode">Cholesterol Measurement</td></tr><tr class="tableroweven"><td>CK [<span class="nci">C64489</span>]</td><td class="codelist-item-decode">Creatine Kinase Measurement</td></tr><tr class="tablerowodd"><td>CL [<span class="nci">C64495</span>]</td><td class="codelist-item-decode">Chloride Measurement</td></tr><tr class="tableroweven"><td>COLOR [<span class="nci">C64546</span>]</td><td class="codelist-item-decode">Color Assessment</td></tr><tr class="tablerowodd"><td>CREAT [<span class="nci">C64547</span>]</td><td class="codelist-item-decode">Creatinine Measurement</td></tr><tr class="tableroweven"><td>EOS [<span class="nci">C64550</span>]</td><td class="codelist-item-decode">Eosinophil Count</td></tr><tr class="tablerowodd"><td>GGT [<span class="nci">C64847</span>]</td><td class="codelist-item-decode">Gamma Glutamyl Transpeptidase Measurement</td></tr><tr class="tableroweven"><td>GLUC [<span class="nci">C105585</span>]</td><td class="codelist-item-decode">Glucose Measurement</td></tr><tr class="tablerowodd"><td>HCT [<span class="nci">C64796</span>]</td><td class="codelist-item-decode">Hematocrit Measurement</td></tr><tr class="tableroweven"><td>HGB [<span class="nci">C64848</span>]</td><td class="codelist-item-decode">Hemoglobin Measurement</td></tr><tr class="tablerowodd"><td>K [<span class="nci">C64853</span>]</td><td class="codelist-item-decode">Potassium Measurement</td></tr><tr class="tableroweven"><td>KETONES [<span class="nci">C64854</span>]</td><td class="codelist-item-decode">Ketone Measurement</td></tr><tr class="tablerowodd"><td>LYM [<span class="nci">C51949</span>]</td><td class="codelist-item-decode">Lymphocyte Count</td></tr><tr class="tableroweven"><td>MACROCY [<span class="nci">C64821</span>]</td><td class="codelist-item-decode">Macrocyte Count</td></tr><tr class="tablerowodd"><td>MCH [<span class="nci">C64797</span>]</td><td class="codelist-item-decode">Erythrocyte Mean Corpuscular Hemoglobin</td></tr><tr class="tableroweven"><td>MCHC [<span class="nci">C64798</span>]</td><td class="codelist-item-decode">Erythrocyte Mean Corpuscular Hemoglobin Concentration</td></tr><tr class="tablerowodd"><td>MCV [<span class="nci">C64799</span>]</td><td class="codelist-item-decode">Erythrocyte Mean Corpuscular Volume</td></tr><tr class="tableroweven"><td>MONO [<span class="nci">C64823</span>]</td><td class="codelist-item-decode">Monocyte Count</td></tr><tr class="tablerowodd"><td>PH [<span class="nci">C45997</span>]</td><td class="codelist-item-decode">pH</td></tr><tr class="tableroweven"><td>PHOS [<span class="nci">C64857</span>]</td><td class="codelist-item-decode">Phosphate Measurement</td></tr><tr class="tablerowodd"><td>PLAT [<span class="nci">C51951</span>]</td><td class="codelist-item-decode">Platelet Count</td></tr><tr class="tableroweven"><td>POIKILO [<span class="nci">C79602</span>]</td><td class="codelist-item-decode">Poikilocyte Measurement</td></tr><tr class="tablerowodd"><td>PROT [<span class="nci">C64858</span>]</td><td class="codelist-item-decode">Total Protein Measurement</td></tr><tr class="tableroweven"><td>RBC [<span class="nci">C51946</span>]</td><td class="codelist-item-decode">Erythrocyte Count</td></tr><tr class="tablerowodd"><td>SODIUM [<span class="nci">C64809</span>]</td><td class="codelist-item-decode">Sodium Measurement</td></tr><tr class="tableroweven"><td>SPGRAV [<span class="nci">C64832</span>]</td><td class="codelist-item-decode">Specific Gravity</td></tr><tr class="tablerowodd"><td>TSH [<span class="nci">C64813</span>]</td><td class="codelist-item-decode">Thyrotropin Measurement</td></tr><tr class="tableroweven"><td>URATE [<span class="nci">C64814</span>]</td><td class="codelist-item-decode">Urate Measurement</td></tr><tr class="tablerowodd"><td>UREAN [<span class="nci">C125949</span>]</td><td class="codelist-item-decode">Urea Nitrogen Measurement</td></tr><tr class="tableroweven"><td>UROBIL [<span class="nci">C64816</span>]</td><td class="codelist-item-decode">Urobilinogen Measurement</td></tr><tr class="tablerowodd"><td>VITB12 [<span class="nci">C64817</span>]</td><td class="codelist-item-decode">Vitamin B12 Measurement</td></tr><tr class="tableroweven"><td>WBC [<span class="nci">C51948</span>]</td><td class="codelist-item-decode">Leukocyte Count</td></tr></table></div><div class="codelist" id="CL.CL.LOC"><div class="codelist-caption">Location [<span class="nci">C74456</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Location"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>ARM [<span class="nci">C32141</span>]</td></tr></table></div><div class="codelist" id="CL.CL.LOC_OE"><div class="codelist-caption">Anatomical Location, subset used for OELOC [<span class="nci">C74456</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Anatomical Location, subset used for OELOC"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>CONJUNCTIVA [<span class="nci">C12341</span>]</td><td class="codelist-item-decode">Conjunctiva</td></tr><tr class="tableroweven"><td>EYE [<span class="nci">C12401</span>]</td><td class="codelist-item-decode">Eye</td></tr><tr class="tablerowodd"><td>EYE, ANTERIOR CHAMBER [<span class="nci">C12667</span>]</td><td class="codelist-item-decode">Anterior Chamber of the Eye</td></tr><tr class="tableroweven"><td>IRIS [<span class="nci">C12737</span>]</td><td class="codelist-item-decode">Iris</td></tr><tr class="tablerowodd"><td>CORNEA [<span class="nci">C12342</span>]</td><td class="codelist-item-decode">Cornea</td></tr></table></div><div class="codelist" id="CL.CL.LOC_VS"><div class="codelist-caption">Anatomical Location [<span class="nci">C74456</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Anatomical Location"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>EAR [<span class="nci">C12394</span>]</td><td class="codelist-item-decode">Ear</td></tr><tr class="tableroweven"><td>ORAL CAVITY [<span class="nci">C12421</span>]</td><td class="codelist-item-decode">Oral Cavity</td></tr></table></div><div class="codelist" id="CL.CL.MHEVDTP"><div class="codelist-caption">Medical History Event Date Type, subset used for MHEVDTP [<span class="nci">C124301</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Medical History Event Date Type, subset used for MHEVDTP"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SYMPTOM ONSET [<span class="nci">C124353</span>]</td><td class="codelist-item-decode">Symptom Onset</td></tr></table></div><div class="codelist" id="CL.CL.MHTERM"><div class="codelist-caption">Medical History Term<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Medical History Term"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ALZHEIMER'S DISEASE</td><td class="codelist-item-decode">Alzheimer's Disease</td></tr></table></div><div class="codelist" id="CL.CL.NCOMPLT"><div class="codelist-caption">Completion/Reason for Non-Completion [<span class="nci">C66727</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Completion/Reason for Non-Completion"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ADVERSE EVENT [<span class="nci">C41331</span>]</td><td class="codelist-item-decode">Adverse Event</td></tr><tr class="tableroweven"><td>COMPLETED [<span class="nci">C25250</span>]</td><td class="codelist-item-decode">Completed</td></tr><tr class="tablerowodd"><td>DEATH [<span class="nci">C28554</span>]</td><td class="codelist-item-decode">Death</td></tr><tr class="tableroweven"><td>LACK OF EFFICACY [<span class="nci">C48226</span>]</td><td class="codelist-item-decode">Lack of Efficacy</td></tr><tr class="tablerowodd"><td>LOST TO FOLLOW-UP [<span class="nci">C48227</span>]</td><td class="codelist-item-decode">Lost to Follow-Up</td></tr><tr class="tableroweven"><td>OTHER [<span class="nci">C17649</span>]</td><td class="codelist-item-decode">Other</td></tr><tr class="tablerowodd"><td>PHYSICIAN DECISION [<span class="nci">C48250</span>]</td><td class="codelist-item-decode">Physician Decision</td></tr><tr class="tableroweven"><td>PREGNANCY [<span class="nci">C25742</span>]</td><td class="codelist-item-decode">Pregnancy</td></tr><tr class="tablerowodd"><td>PROTOCOL DEVIATION [<span class="nci">C48251</span>]</td><td class="codelist-item-decode">Protocol Deviation</td></tr><tr class="tableroweven"><td>SCREEN FAILURE [<span class="nci">C49628</span>]</td><td class="codelist-item-decode">Screen Failure</td></tr><tr class="tablerowodd"><td>STUDY TERMINATED BY SPONSOR [<span class="nci">C49632</span>]</td><td class="codelist-item-decode">Study Terminated By Sponsor</td></tr><tr class="tableroweven"><td>WITHDRAWAL BY PARENT/GUARDIAN [<span class="nci">C102355</span>]</td><td class="codelist-item-decode">Withdrawal By Parent/Guardian</td></tr><tr class="tablerowodd"><td>WITHDRAWAL BY SUBJECT [<span class="nci">C49634</span>]</td><td class="codelist-item-decode">Withdrawal By Subject</td></tr></table></div><div class="codelist" id="CL.CL.ND"><div class="codelist-caption">Not Done [<span class="nci">C66789</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Not Done"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>NOT DONE [<span class="nci">C49484</span>]</td><td class="codelist-item-decode">Not Done</td></tr></table></div><div class="codelist" id="CL.CL.NORMABNM"><div class="codelist-caption">Normal Abnormal Response, subset used in OE and NV. [<span class="nci">C101834</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Normal Abnormal Response, subset used in OE and NV."><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ABNORMAL [<span class="nci">C25401</span>]</td><td class="codelist-item-decode">Abnormal</td></tr><tr class="tableroweven"><td>NORMAL [<span class="nci">C14165</span>]</td><td class="codelist-item-decode">Normal</td></tr></table></div><div class="codelist" id="CL.CL.NRIND"><div class="codelist-caption">Normal Range Indicator [<span class="nci">C78736</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Normal Range Indicator"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ABNORMAL [<span class="nci">C78802</span>]</td><td class="codelist-item-decode">Abnormal</td></tr><tr class="tableroweven"><td>HIGH [<span class="nci">C78800</span>]</td><td class="codelist-item-decode">High</td></tr><tr class="tablerowodd"><td>LOW [<span class="nci">C78801</span>]</td><td class="codelist-item-decode">Low</td></tr><tr class="tableroweven"><td>NORMAL [<span class="nci">C78727</span>]</td><td class="codelist-item-decode">Normal</td></tr></table></div><div class="codelist" id="CL.CL.NVTEST"><div class="codelist-caption">Nervous System Test [<span class="nci">C116103</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Nervous System Test"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Interpretation [<span class="extended">*</span>]</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.CL.NVTESTCD"><div class="codelist-caption">Nervous System Test Code [<span class="nci">C116104</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Nervous System Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>INTP [<span class="extended">*</span>]</td><td class="codelist-item-decode">Interpretation</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.CL.NY_NY"><div class="codelist-caption">No Yes Response, subset for variables with only "Y" or "N" val [<span class="nci">C66742</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - No Yes Response, subset for variables with only &#34;Y&#34; or &#34;N&#34; val"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>N [<span class="nci">C49487</span>]</td><td class="codelist-item-decode">No</td></tr><tr class="tableroweven"><td>Y [<span class="nci">C49488</span>]</td><td class="codelist-item-decode">Yes</td></tr></table></div><div class="codelist" id="CL.CL.NY_YONLY"><div class="codelist-caption">No Yes Response, subset for variables with only "Y" or null values [<span class="nci">C66742</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - No Yes Response, subset for variables with only &#34;Y&#34; or null values"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Y [<span class="nci">C49488</span>]</td><td class="codelist-item-decode">Yes</td></tr></table></div><div class="codelist" id="CL.CL.OEFOCUS"><div class="codelist-caption">Ophthalmic Focus of Study Specific Interest [<span class="nci">C119013</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Ophthalmic Focus of Study Specific Interest"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>OD [<span class="nci">C119333</span>]</td><td class="codelist-item-decode">Right Eye</td></tr><tr class="tableroweven"><td>OS [<span class="nci">C119334</span>]</td><td class="codelist-item-decode">Left Eye</td></tr></table></div><div class="codelist" id="CL.CL.OEMETHOD"><div class="codelist-caption">Method, subset used for OEMETHOD [<span class="nci">C85492</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Method, subset used for OEMETHOD"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SLIT LAMP [<span class="nci">C75583</span>]</td><td class="codelist-item-decode">Slit-lamp Examination</td></tr></table></div><div class="codelist" id="CL.CL.OETEST"><div class="codelist-caption">Ophthalmic Exam Test [<span class="nci">C117742</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Ophthalmic Exam Test"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Abnormality Detail [<span class="extended">*</span>]</td></tr><tr class="tableroweven"><td>Interpretation [<span class="nci">C41255</span>]</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.CL.OETESTCD"><div class="codelist-caption">Ophthalmic Exam Test Code [<span class="nci">C117743</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Ophthalmic Exam Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ABDETAIL [<span class="extended">*</span>]</td><td class="codelist-item-decode">Abnormality Detail</td></tr><tr class="tableroweven"><td>INTP [<span class="nci">C41255</span>]</td><td class="codelist-item-decode">Interpretation</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.CL.OUT"><div class="codelist-caption">Outcome of Event [<span class="nci">C66768</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Outcome of Event"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>FATAL [<span class="nci">C48275</span>]</td><td class="codelist-item-decode">Fatal</td></tr><tr class="tableroweven"><td>NOT RECOVERED/NOT RESOLVED [<span class="nci">C49494</span>]</td><td class="codelist-item-decode">Not Recovered/Not Resolved</td></tr><tr class="tablerowodd"><td>RECOVERED/RESOLVED [<span class="nci">C49498</span>]</td><td class="codelist-item-decode">Recovered/Resolved</td></tr><tr class="tableroweven"><td>RECOVERED/RESOLVED WITH SEQUELAE [<span class="nci">C49495</span>]</td><td class="codelist-item-decode">Recovered/Resolved With Sequelae</td></tr><tr class="tablerowodd"><td>RECOVERING/RESOLVING [<span class="nci">C49496</span>]</td><td class="codelist-item-decode">Recovering/Resolving</td></tr><tr class="tableroweven"><td>UNKNOWN [<span class="nci">C17998</span>]</td><td class="codelist-item-decode">Unknown</td></tr></table></div><div class="codelist" id="CL.CL.PHQ01C"><div class="codelist-caption">Patient Health Questionnaire - 9 Item Questionnaire Test Code [<span class="nci">C103481</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Patient Health Questionnaire - 9 Item Questionnaire Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>PHQ0101 [<span class="nci">C103705</span>]</td><td class="codelist-item-decode">PHQ01-Little Interest/Pleasure in Things</td></tr><tr class="tableroweven"><td>PHQ0102 [<span class="nci">C103706</span>]</td><td class="codelist-item-decode">PHQ01-Feeling Down Depressed or Hopeless</td></tr><tr class="tablerowodd"><td>PHQ0103 [<span class="nci">C103707</span>]</td><td class="codelist-item-decode">PHQ01-Trouble Falling or Staying Asleep</td></tr><tr class="tableroweven"><td>PHQ0104 [<span class="nci">C103708</span>]</td><td class="codelist-item-decode">PHQ01-Feeling Tired or Little Energy</td></tr><tr class="tablerowodd"><td>PHQ0105 [<span class="nci">C103709</span>]</td><td class="codelist-item-decode">PHQ01-Poor Appetite or Overeating</td></tr><tr class="tableroweven"><td>PHQ0106 [<span class="nci">C103710</span>]</td><td class="codelist-item-decode">PHQ01-Feeling Bad About Yourself</td></tr><tr class="tablerowodd"><td>PHQ0107 [<span class="nci">C103711</span>]</td><td class="codelist-item-decode">PHQ01-Trouble Concentrating on Things</td></tr><tr class="tableroweven"><td>PHQ0108 [<span class="nci">C103712</span>]</td><td class="codelist-item-decode">PHQ01-Moving Slowly or Fidgety/Restless</td></tr><tr class="tablerowodd"><td>PHQ0109 [<span class="nci">C103713</span>]</td><td class="codelist-item-decode">PHQ01-Thoughts You Be Better Off Dead</td></tr><tr class="tableroweven"><td>PHQ0110 [<span class="nci">C103714</span>]</td><td class="codelist-item-decode">PHQ01-Difficult to Work/Take Care Things</td></tr><tr class="tablerowodd"><td>PHQ0111 [<span class="nci">C113887</span>]</td><td class="codelist-item-decode">PHQ01-Total Score</td></tr></table></div><div class="codelist" id="CL.CL.PHQ01R"><div class="codelist-caption">Patient Health Questionnaire Responses<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Patient Health Questionnaire Responses"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Not at all</td></tr><tr class="tableroweven"><td>Several days</td></tr><tr class="tablerowodd"><td>More than half the days</td></tr><tr class="tableroweven"><td>Nearly every day</td></tr></table></div><div class="codelist" id="CL.CL.PHQ01RQ10"><div class="codelist-caption">Patient Health Questionnaire Responses-Question 10<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Patient Health Questionnaire Responses-Question 10"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Not difficult at all</td></tr><tr class="tableroweven"><td>Somewhat difficult</td></tr><tr class="tablerowodd"><td>Very difficult</td></tr><tr class="tableroweven"><td>Extremely Difficult</td></tr></table></div><div class="codelist" id="CL.CL.PHQ01RS"><div class="codelist-caption">Patient Health Questionnaire Responses Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Patient Health Questionnaire Responses Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Not at all</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Several days</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">More than half the days</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">Nearly every day</td></tr></table></div><div class="codelist" id="CL.CL.PHQ01T"><div class="codelist-caption">Patient Health Questionnaire - 9 Item Questionnaire Test Name [<span class="nci">C103480</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Patient Health Questionnaire - 9 Item Questionnaire Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>PHQ01-Difficult to Work/Take Care Things [<span class="nci">C103714</span>]</td></tr><tr class="tableroweven"><td>PHQ01-Feeling Bad About Yourself [<span class="nci">C103710</span>]</td></tr><tr class="tablerowodd"><td>PHQ01-Feeling Down Depressed or Hopeless [<span class="nci">C103706</span>]</td></tr><tr class="tableroweven"><td>PHQ01-Feeling Tired or Little Energy [<span class="nci">C103708</span>]</td></tr><tr class="tablerowodd"><td>PHQ01-Little Interest/Pleasure in Things [<span class="nci">C103705</span>]</td></tr><tr class="tableroweven"><td>PHQ01-Moving Slowly or Fidgety/Restless [<span class="nci">C103712</span>]</td></tr><tr class="tablerowodd"><td>PHQ01-Poor Appetite or Overeating [<span class="nci">C103709</span>]</td></tr><tr class="tableroweven"><td>PHQ01-Thoughts You Be Better Off Dead [<span class="nci">C103713</span>]</td></tr><tr class="tablerowodd"><td>PHQ01-Total Score [<span class="nci">C113887</span>]</td></tr><tr class="tableroweven"><td>PHQ01-Trouble Concentrating on Things [<span class="nci">C103711</span>]</td></tr><tr class="tablerowodd"><td>PHQ01-Trouble Falling or Staying Asleep [<span class="nci">C103707</span>]</td></tr></table></div><div class="codelist" id="CL.CL.POSITION_VS"><div class="codelist-caption">Position, subset to be used for VSPOS [<span class="nci">C71148</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Position, subset to be used for VSPOS"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>STANDING [<span class="nci">C62166</span>]</td><td class="codelist-item-decode">Standing</td></tr><tr class="tableroweven"><td>SUPINE [<span class="nci">C62167</span>]</td><td class="codelist-item-decode">Supine</td></tr></table></div><div class="codelist" id="CL.CL.PROTMLST"><div class="codelist-caption">Protocol Milestone [<span class="nci">C114118</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Protocol Milestone"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>INFORMED CONSENT OBTAINED [<span class="nci">C16735</span>]</td><td class="codelist-item-decode">Informed Consent</td></tr></table></div><div class="codelist" id="CL.CL.QSCAT_PH"><div class="codelist-caption">Category of Questionnaire for PHQ-9 [<span class="nci">C100129</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Category of Questionnaire for PHQ-9"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>PHQ-9 [<span class="nci">C103526</span>]</td><td class="codelist-item-decode">Patient Health Questionnaire - 9 Item</td></tr></table></div><div class="codelist" id="CL.CL.QSCAT_SL"><div class="codelist-caption">Category of Questionnaire for SWLS [<span class="nci">C100129</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Category of Questionnaire for SWLS"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SWLS [<span class="nci">C115799</span>]</td><td class="codelist-item-decode">Satisfaction With Life Scale Questionnaire</td></tr></table></div><div class="codelist" id="CL.CL.RACE"><div class="codelist-caption">Race [<span class="nci">C74457</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Race"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>AMERICAN INDIAN OR ALASKA NATIVE [<span class="nci">C41259</span>]</td><td class="codelist-item-decode">American Indian Or Alaska Native</td></tr><tr class="tableroweven"><td>ASIAN [<span class="nci">C41260</span>]</td><td class="codelist-item-decode">Asian</td></tr><tr class="tablerowodd"><td>BLACK OR AFRICAN AMERICAN [<span class="nci">C16352</span>]</td><td class="codelist-item-decode">Black Or African American</td></tr><tr class="tableroweven"><td>NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [<span class="nci">C41219</span>]</td><td class="codelist-item-decode">Native Hawaiian Or Other Pacific Islander</td></tr><tr class="tablerowodd"><td>WHITE [<span class="nci">C41261</span>]</td><td class="codelist-item-decode">White</td></tr></table></div><div class="codelist" id="CL.CL.RACEMULT"><div class="codelist-caption">Race Multiple Selections<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Race Multiple Selections"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>MULTIPLE</td><td class="codelist-item-decode">Multiple</td></tr></table></div><div class="codelist" id="CL.CL.RDOMAIN_RELREC"><div class="codelist-caption">SDTM Domain Abbreviation, subset used for RELREC [<span class="nci">C66734</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - SDTM Domain Abbreviation, subset used for RELREC"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>AE [<span class="nci">C49562</span>]</td><td class="codelist-item-decode">Adverse Events</td></tr><tr class="tableroweven"><td>DS [<span class="nci">C49576</span>]</td><td class="codelist-item-decode">Disposition</td></tr><tr class="tablerowodd"><td>DD [<span class="nci">C95087</span>]</td><td class="codelist-item-decode">Death Details</td></tr><tr class="tableroweven"><td>FA [<span class="nci">C85442</span>]</td><td class="codelist-item-decode">Findings About Events or Interventions</td></tr></table></div><div class="codelist" id="CL.CL.RELTYPE"><div class="codelist-caption">Relationship Type [<span class="nci">C78737</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Relationship Type"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>MANY [<span class="nci">C78728</span>]</td><td class="codelist-item-decode">Many</td></tr><tr class="tableroweven"><td>ONE [<span class="nci">C66832</span>]</td><td class="codelist-item-decode">One</td></tr></table></div><div class="codelist" id="CL.CL.ROUTE_CM"><div class="codelist-caption">Route of Administration, subset to be used for CM [<span class="nci">C66729</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Route of Administration, subset to be used for CM"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ORAL [<span class="nci">C38288</span>]</td><td class="codelist-item-decode">Oral</td></tr><tr class="tableroweven"><td>TOPICAL [<span class="nci">C38304</span>]</td><td class="codelist-item-decode">Topical</td></tr><tr class="tablerowodd"><td>INTRAVENOUS [<span class="nci">C38276</span>]</td><td class="codelist-item-decode">Intravenous</td></tr><tr class="tableroweven"><td>NASAL [<span class="nci">C38284</span>]</td><td class="codelist-item-decode">Nasal</td></tr><tr class="tablerowodd"><td>RESPIRATORY (INHALATION) [<span class="nci">C38216</span>]</td><td class="codelist-item-decode">Inhalation Route of Administration</td></tr><tr class="tableroweven"><td>TRANSDERMAL [<span class="nci">C38305</span>]</td><td class="codelist-item-decode">Transdermal</td></tr></table></div><div class="codelist" id="CL.CL.ROUTE_ECEX"><div class="codelist-caption">Route of Administration, subset to be used for EC and EX [<span class="nci">C66729</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Route of Administration, subset to be used for EC and EX"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SUBCUTANEOUS [<span class="nci">C38299</span>]</td><td class="codelist-item-decode">Subcutaneous Route of Administration</td></tr></table></div><div class="codelist" id="CL.CL.RSCAT"><div class="codelist-caption">Category of Clinical Classification, subset to be used for RSCAT [<span class="nci">C118971</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Category of Clinical Classification, subset to be used for RSCAT"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>HAMD 17 [<span class="nci">C100767</span>]</td><td class="codelist-item-decode">Hamilton Depression Rating Scale 17 Item Clinical Classification</td></tr></table></div><div class="codelist" id="CL.CL.SEX"><div class="codelist-caption">Sex Male Female [<span class="nci">C66731</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Sex Male Female"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>F [<span class="nci">C16576</span>]</td><td class="codelist-item-decode">Female</td></tr><tr class="tableroweven"><td>M [<span class="nci">C20197</span>]</td><td class="codelist-item-decode">Male</td></tr></table></div><div class="codelist" id="CL.CL.SITEID"><div class="codelist-caption">Site Identifier<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Site Identifier"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>701</td></tr><tr class="tableroweven"><td>704</td></tr><tr class="tablerowodd"><td>708</td></tr><tr class="tableroweven"><td>710</td></tr><tr class="tablerowodd"><td>711</td></tr><tr class="tableroweven"><td>718</td></tr></table></div><div class="codelist" id="CL.CL.STYPE"><div class="codelist-caption">Study Type Response [<span class="nci">C99077</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Study Type Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>INTERVENTIONAL [<span class="nci">C98388</span>]</td><td class="codelist-item-decode">Interventional</td></tr></table></div><div class="codelist" id="CL.CL.SWLS01TC"><div class="codelist-caption">Satisfaction With Life Scale Questionnaire Test Code [<span class="nci">C115408</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Satisfaction With Life Scale Questionnaire Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SWLS0101 [<span class="nci">C115895</span>]</td><td class="codelist-item-decode">SWLS01-Have Gotten Important Things</td></tr><tr class="tableroweven"><td>SWLS0102 [<span class="nci">C115896</span>]</td><td class="codelist-item-decode">SWLS01-I Am Satisfied with My Life</td></tr><tr class="tablerowodd"><td>SWLS0103 [<span class="nci">C115897</span>]</td><td class="codelist-item-decode">SWLS01-Live Life Over Change Nothing</td></tr><tr class="tableroweven"><td>SWLS0104 [<span class="nci">C115898</span>]</td><td class="codelist-item-decode">SWLS01-My Life Conditions are Excellent</td></tr><tr class="tablerowodd"><td>SWLS0105 [<span class="nci">C115899</span>]</td><td class="codelist-item-decode">SWLS01-My Life is Close to Ideal</td></tr></table></div><div class="codelist" id="CL.CL.SWLS01TN"><div class="codelist-caption">Satisfaction With Life Scale Questionnaire Test Name [<span class="nci">C115407</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Satisfaction With Life Scale Questionnaire Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SWLS01-Have Gotten Important Things [<span class="nci">C115898</span>]</td></tr><tr class="tableroweven"><td>SWLS01-I Am Satisfied with My Life [<span class="nci">C115897</span>]</td></tr><tr class="tablerowodd"><td>SWLS01-Live Life Over Change Nothing [<span class="nci">C115899</span>]</td></tr><tr class="tableroweven"><td>SWLS01-My Life Conditions are Excellent [<span class="nci">C115896</span>]</td></tr><tr class="tablerowodd"><td>SWLS01-My Life is Close to Ideal [<span class="nci">C115895</span>]</td></tr></table></div><div class="codelist" id="CL.CL.SWLSR"><div class="codelist-caption">SWLS-Responses<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - SWLS-Responses"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Strongly disagree</td></tr><tr class="tableroweven"><td>Disagree</td></tr><tr class="tablerowodd"><td>Slightly disagree</td></tr><tr class="tableroweven"><td>Neither agree nor disagree</td></tr><tr class="tablerowodd"><td>Slightly agree</td></tr><tr class="tableroweven"><td>Agree</td></tr><tr class="tablerowodd"><td>Strongly agree</td></tr></table></div><div class="codelist" id="CL.CL.SWLSR_S"><div class="codelist-caption">SWLS-Responses Standardized<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - SWLS-Responses Standardized"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">Strongly disagree</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Disagree</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">Slightly disagree</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">Neither agree nor disagree</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">Slightly agree</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Agree</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">Strongly agree</td></tr></table></div><div class="codelist" id="CL.CL.TBLIND"><div class="codelist-caption">Trial Blinding Schema Response [<span class="nci">C66735</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Trial Blinding Schema Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DOUBLE BLIND [<span class="nci">C15228</span>]</td><td class="codelist-item-decode">Double Blind</td></tr></table></div><div class="codelist" id="CL.CL.TCNTRL"><div class="codelist-caption">Control Type Response [<span class="nci">C66785</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Control Type Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>PLACEBO [<span class="nci">C49648</span>]</td><td class="codelist-item-decode">Placebo</td></tr></table></div><div class="codelist" id="CL.CL.TINDTP"><div class="codelist-caption">Trial Intent Type Response [<span class="nci">C66736</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Trial Intent Type Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>TREATMENT [<span class="nci">C49656</span>]</td><td class="codelist-item-decode">Treatment</td></tr></table></div><div class="codelist" id="CL.CL.TPHASE"><div class="codelist-caption">Trial Phase Response [<span class="nci">C66737</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Trial Phase Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>PHASE II TRIAL [<span class="nci">C15601</span>]</td><td class="codelist-item-decode">Phase II Trial</td></tr></table></div><div class="codelist" id="CL.CL.TSPARM"><div class="codelist-caption">Trial Summary Parameter Test Name [<span class="nci">C67152</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Trial Summary Parameter Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Actual Number of Subjects [<span class="nci">C98703</span>]</td></tr><tr class="tableroweven"><td>Adaptive Design [<span class="nci">C146995</span>]</td></tr><tr class="tablerowodd"><td>Added on to Existing Treatments [<span class="nci">C49703</span>]</td></tr><tr class="tableroweven"><td>Planned Maximum Age of Subjects [<span class="nci">C49694</span>]</td></tr><tr class="tablerowodd"><td>Planned Minimum Age of Subjects [<span class="nci">C49693</span>]</td></tr><tr class="tableroweven"><td>Data Cutoff Description [<span class="nci">C98718</span>]</td></tr><tr class="tablerowodd"><td>Data Cutoff Date [<span class="nci">C98717</span>]</td></tr><tr class="tableroweven"><td>Dose per Administration [<span class="nci">C25488</span>]</td></tr><tr class="tablerowodd"><td>Dose Form [<span class="nci">C42636</span>]</td></tr><tr class="tableroweven"><td>Dosing Frequency [<span class="nci">C89081</span>]</td></tr><tr class="tablerowodd"><td>Dose Units [<span class="nci">C73558</span>]</td></tr><tr class="tableroweven"><td>Planned Country of Investigational Sites [<span class="nci">C98770</span>]</td></tr><tr class="tablerowodd"><td>Healthy Subject Indicator [<span class="nci">C98737</span>]</td></tr><tr class="tableroweven"><td>Trial Disease/Condition Indication [<span class="nci">C112038</span>]</td></tr><tr class="tablerowodd"><td>Intervention Model [<span class="nci">C98746</span>]</td></tr><tr class="tableroweven"><td>Intervention Type [<span class="nci">C98747</span>]</td></tr><tr class="tablerowodd"><td>Trial Length [<span class="nci">C49697</span>]</td></tr><tr class="tableroweven"><td>Planned Number of Arms [<span class="nci">C98771</span>]</td></tr><tr class="tablerowodd"><td>Trial Primary Objective [<span class="nci">C85826</span>]</td></tr><tr class="tableroweven"><td>Trial Secondary Objective [<span class="nci">C85827</span>]</td></tr><tr class="tablerowodd"><td>Primary Outcome Measure [<span class="nci">C98772</span>]</td></tr><tr class="tableroweven"><td>Secondary Outcome Measure [<span class="nci">C98781</span>]</td></tr><tr class="tablerowodd"><td>Pharmacologic Class [<span class="nci">C98768</span>]</td></tr><tr class="tableroweven"><td>Planned Number of Subjects [<span class="nci">C49692</span>]</td></tr><tr class="tablerowodd"><td>Trial is Randomized [<span class="nci">C25196</span>]</td></tr><tr class="tableroweven"><td>Randomization Quotient [<span class="nci">C98775</span>]</td></tr><tr class="tablerowodd"><td>Registry Identifier [<span class="nci">C98714</span>]</td></tr><tr class="tableroweven"><td>Route of Administration [<span class="nci">C38114</span>]</td></tr><tr class="tablerowodd"><td>SDTM IG Version [<span class="nci">C156604</span>]</td></tr><tr class="tableroweven"><td>SDTM Version [<span class="nci">C156605</span>]</td></tr><tr class="tablerowodd"><td>Study End Date [<span class="nci">C90462</span>]</td></tr><tr class="tableroweven"><td>Sex of Participants [<span class="nci">C49696</span>]</td></tr><tr class="tablerowodd"><td>Clinical Study Sponsor [<span class="nci">C70793</span>]</td></tr><tr class="tableroweven"><td>Study Start Date [<span class="nci">C69208</span>]</td></tr><tr class="tablerowodd"><td>Study Stop Rules [<span class="nci">C49698</span>]</td></tr><tr class="tableroweven"><td>Study Type [<span class="nci">C142175</span>]</td></tr><tr class="tablerowodd"><td>Trial Blinding Schema [<span class="nci">C49658</span>]</td></tr><tr class="tableroweven"><td>Control Type [<span class="nci">C49647</span>]</td></tr><tr class="tablerowodd"><td>Diagnosis Group [<span class="nci">C49650</span>]</td></tr><tr class="tableroweven"><td>Trial Intent Type [<span class="nci">C49652</span>]</td></tr><tr class="tablerowodd"><td>Trial Title [<span class="nci">C49802</span>]</td></tr><tr class="tableroweven"><td>Trial Phase Classification [<span class="nci">C48281</span>]</td></tr><tr class="tablerowodd"><td>Investigational Therapy or Treatment [<span class="nci">C41161</span>]</td></tr><tr class="tableroweven"><td>Trial Type [<span class="nci">C49660</span>]</td></tr></table></div><div class="codelist" id="CL.CL.TSPARMCD"><div class="codelist-caption">Trial Summary Parameter Test Code [<span class="nci">C66738</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Trial Summary Parameter Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ACTSUB [<span class="nci">C98703</span>]</td><td class="codelist-item-decode">Actual Subject Number</td></tr><tr class="tableroweven"><td>ADAPT [<span class="nci">C146995</span>]</td><td class="codelist-item-decode">Adaptive Study Design Indicator</td></tr><tr class="tablerowodd"><td>ADDON [<span class="nci">C49703</span>]</td><td class="codelist-item-decode">Test Product Added to Existing Treatment</td></tr><tr class="tableroweven"><td>AGEMAX [<span class="nci">C49694</span>]</td><td class="codelist-item-decode">Planned Maximum Age of Subjects</td></tr><tr class="tablerowodd"><td>AGEMIN [<span class="nci">C49693</span>]</td><td class="codelist-item-decode">Planned Minimum Age of Subjects</td></tr><tr class="tableroweven"><td>DCUTDESC [<span class="nci">C98718</span>]</td><td class="codelist-item-decode">Data Cutoff Date Description</td></tr><tr class="tablerowodd"><td>DCUTDTC [<span class="nci">C98717</span>]</td><td class="codelist-item-decode">Data Cutoff Date</td></tr><tr class="tableroweven"><td>DOSE [<span class="nci">C25488</span>]</td><td class="codelist-item-decode">Dose</td></tr><tr class="tablerowodd"><td>DOSFRM [<span class="nci">C42636</span>]</td><td class="codelist-item-decode">Pharmaceutical Dosage Form</td></tr><tr class="tableroweven"><td>DOSFRQ [<span class="nci">C89081</span>]</td><td class="codelist-item-decode">Dose Frequency</td></tr><tr class="tablerowodd"><td>DOSU [<span class="nci">C73558</span>]</td><td class="codelist-item-decode">Dosage Form Unit</td></tr><tr class="tableroweven"><td>FCNTRY [<span class="nci">C98770</span>]</td><td class="codelist-item-decode">Planned Country of Investigational Site</td></tr><tr class="tablerowodd"><td>HLTSUBJI [<span class="nci">C98737</span>]</td><td class="codelist-item-decode">Healthy Subject Indicator</td></tr><tr class="tableroweven"><td>INDIC [<span class="nci">C112038</span>]</td><td class="codelist-item-decode">Trial Indication</td></tr><tr class="tablerowodd"><td>INTMODEL [<span class="nci">C98746</span>]</td><td class="codelist-item-decode">Intervention Model</td></tr><tr class="tableroweven"><td>INTTYPE [<span class="nci">C98747</span>]</td><td class="codelist-item-decode">Intervention Type</td></tr><tr class="tablerowodd"><td>LENGTH [<span class="nci">C49697</span>]</td><td class="codelist-item-decode">Trial Length</td></tr><tr class="tableroweven"><td>NARMS [<span class="nci">C98771</span>]</td><td class="codelist-item-decode">Planned Number of Arms</td></tr><tr class="tablerowodd"><td>OBJPRIM [<span class="nci">C85826</span>]</td><td class="codelist-item-decode">Trial Primary Objective</td></tr><tr class="tableroweven"><td>OBJSEC [<span class="nci">C85827</span>]</td><td class="codelist-item-decode">Trial Secondary Objective</td></tr><tr class="tablerowodd"><td>OUTMSPRI [<span class="nci">C98772</span>]</td><td class="codelist-item-decode">Primary Outcome Measure</td></tr><tr class="tableroweven"><td>OUTMSSEC [<span class="nci">C98781</span>]</td><td class="codelist-item-decode">Secondary Outcome Measure</td></tr><tr class="tablerowodd"><td>PCLAS [<span class="nci">C98768</span>]</td><td class="codelist-item-decode">Pharmacological Class of Investigational Therapy</td></tr><tr class="tableroweven"><td>PLANSUB [<span class="nci">C49692</span>]</td><td class="codelist-item-decode">Planned Subject Number</td></tr><tr class="tablerowodd"><td>RANDOM [<span class="nci">C25196</span>]</td><td class="codelist-item-decode">Randomization</td></tr><tr class="tableroweven"><td>RANDQT [<span class="nci">C98775</span>]</td><td class="codelist-item-decode">Randomization Quotient</td></tr><tr class="tablerowodd"><td>REGID [<span class="nci">C98714</span>]</td><td class="codelist-item-decode">Clinical Trial Registry Identifier</td></tr><tr class="tableroweven"><td>ROUTE [<span class="nci">C38114</span>]</td><td class="codelist-item-decode">Route of Administration</td></tr><tr class="tablerowodd"><td>SDTIGVER [<span class="nci">C156604</span>]</td><td class="codelist-item-decode">Study Data Tabulation Model Implementation Guide Version</td></tr><tr class="tableroweven"><td>SDTMVER [<span class="nci">C156605</span>]</td><td class="codelist-item-decode">Study Data Tabulation Model Version</td></tr><tr class="tablerowodd"><td>SENDTC [<span class="nci">C90462</span>]</td><td class="codelist-item-decode">Clinical Study End Date</td></tr><tr class="tableroweven"><td>SEXPOP [<span class="nci">C49696</span>]</td><td class="codelist-item-decode">Sex of Study Group</td></tr><tr class="tablerowodd"><td>SPONSOR [<span class="nci">C70793</span>]</td><td class="codelist-item-decode">Clinical Study Sponsor</td></tr><tr class="tableroweven"><td>SSTDTC [<span class="nci">C69208</span>]</td><td class="codelist-item-decode">Study Start Date</td></tr><tr class="tablerowodd"><td>STOPRULE [<span class="nci">C49698</span>]</td><td class="codelist-item-decode">Study Stop Rule</td></tr><tr class="tableroweven"><td>STYPE [<span class="nci">C142175</span>]</td><td class="codelist-item-decode">Study Type</td></tr><tr class="tablerowodd"><td>TBLIND [<span class="nci">C49658</span>]</td><td class="codelist-item-decode">Trial Blinding Schema</td></tr><tr class="tableroweven"><td>TCNTRL [<span class="nci">C49647</span>]</td><td class="codelist-item-decode">Control Type</td></tr><tr class="tablerowodd"><td>TDIGRP [<span class="nci">C49650</span>]</td><td class="codelist-item-decode">Diagnosis Group</td></tr><tr class="tableroweven"><td>TINDTP [<span class="nci">C49652</span>]</td><td class="codelist-item-decode">Clinical Study by Intent</td></tr><tr class="tablerowodd"><td>TITLE [<span class="nci">C49802</span>]</td><td class="codelist-item-decode">Trial Title</td></tr><tr class="tableroweven"><td>TPHASE [<span class="nci">C48281</span>]</td><td class="codelist-item-decode">Trial Phase</td></tr><tr class="tablerowodd"><td>TRT [<span class="nci">C41161</span>]</td><td class="codelist-item-decode">Protocol Agent</td></tr><tr class="tableroweven"><td>TTYPE [<span class="nci">C49660</span>]</td><td class="codelist-item-decode">Trial Type</td></tr></table></div><div class="codelist" id="CL.CL.TTYPE"><div class="codelist-caption">Trial Type Response [<span class="nci">C66739</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Trial Type Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>EFFICACY [<span class="nci">C49666</span>]</td><td class="codelist-item-decode">Efficacy</td></tr><tr class="tableroweven"><td>PHARMACOKINETIC [<span class="nci">C49663</span>]</td><td class="codelist-item-decode">Pharmacokinetic</td></tr><tr class="tablerowodd"><td>SAFETY [<span class="nci">C49667</span>]</td><td class="codelist-item-decode">Safety</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_CM"><div class="codelist-caption">Unit, subset to be used for CMDOSU [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used for CMDOSU"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mg [<span class="nci">C28253</span>]</td><td class="codelist-item-decode">Milligram</td></tr><tr class="tableroweven"><td>ng [<span class="nci">C48516</span>]</td><td class="codelist-item-decode">Nanogram</td></tr><tr class="tablerowodd"><td>TABLET [<span class="nci">C42998</span>]</td><td class="codelist-item-decode">Tablet</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_ECDOSU"><div class="codelist-caption">Unit, subset to be used for ECDOSU [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used for ECDOSU"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mL [<span class="nci">C25613</span>]</td><td class="codelist-item-decode">Milliliter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_ECPSTRGU"><div class="codelist-caption">Unit, subset to be used for ECPSTRGU [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used for ECPSTRGU"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>g/L [<span class="nci">C42576</span>]</td><td class="codelist-item-decode">Gram per Liter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_EX"><div class="codelist-caption">Unit, subset to be used for EXDOSU [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used for EXDOSU"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mg [<span class="nci">C28253</span>]</td><td class="codelist-item-decode">Milligram</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_10^12/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with 10^12/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with 10^12/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>10^12/L [<span class="nci">C67308</span>]</td><td class="codelist-item-decode">Million per Microliter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_10^9/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with 10^9/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with 10^9/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>10^9/L [<span class="nci">C67255</span>]</td><td class="codelist-item-decode">Billion per Liter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_PCT"><div class="codelist-caption">Unit, subset to be used in VLM for tests with % as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with % as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>% [<span class="nci">C25613</span>]</td><td class="codelist-item-decode">Percentage</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_U/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with U/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with U/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>U/L [<span class="nci">C67456</span>]</td><td class="codelist-item-decode">Unit per Liter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_fL"><div class="codelist-caption">Unit, subset to be used in VLM for tests with fL as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with fL as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>fL [<span class="nci">C64780</span>]</td><td class="codelist-item-decode">Femtoliter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_fmol"><div class="codelist-caption">Unit, subset to be used in VLM for tests with fmol as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with fmol as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>fmol [<span class="nci">C42576</span>]</td><td class="codelist-item-decode">Femtomole</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_g/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with g/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with g/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>g/L [<span class="nci">C68854</span>]</td><td class="codelist-item-decode">Femtomole</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_g/dL"><div class="codelist-caption">Unit, subset to be used in VLM for tests with g/dL as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with g/dL as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>g/dL [<span class="nci">C64783</span>]</td><td class="codelist-item-decode">Gram per Deciliter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_mEq/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with mEq/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with mEq/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mEq/L [<span class="nci">C67474</span>]</td><td class="codelist-item-decode">Milliequivalent Per Liter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_mIU/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with mIU/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with mIU/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mIU/L [<span class="nci">C67405</span>]</td><td class="codelist-item-decode">Microinternational Unit per Milliliter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_mU/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with mU/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with mU/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mU/L [<span class="nci">C48508</span>]</td><td class="codelist-item-decode">Microunit per Milliliter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_mg/dL"><div class="codelist-caption">Unit, subset to be used in VLM for tests with mg/dL as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with mg/dL as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mg/dL [<span class="nci">C67015</span>]</td><td class="codelist-item-decode">Milligram per Deciliter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_mmol/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with mmol/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with mmol/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mmol/L [<span class="nci">C64387</span>]</td><td class="codelist-item-decode">Millimole per Liter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_ng/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with ng/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with ng/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ng/L [<span class="nci">C67327</span>]</td><td class="codelist-item-decode">Nanogram per Liter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_pg"><div class="codelist-caption">Unit, subset to be used in VLM for tests with pg as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with pg as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>pg [<span class="nci">C64551</span>]</td><td class="codelist-item-decode">Picogram</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_pmol/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with pmol/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with pmol/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>pmol/L [<span class="nci">C67434</span>]</td><td class="codelist-item-decode">Picomole per Liter</td></tr></table></div><div class="codelist" id="CL.CL.UNIT_LB_umol/L"><div class="codelist-caption">Unit, subset to be used in VLM for tests with umol/L as the unit [<span class="nci">C71620</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Unit, subset to be used in VLM for tests with umol/L as the unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>umol/L [<span class="nci">C67408</span>]</td><td class="codelist-item-decode">Micromole per Liter</td></tr></table></div><div class="codelist" id="CL.CL.VSTEST"><div class="codelist-caption">Vital Signs Test Name [<span class="nci">C67153</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Vital Signs Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Diastolic Blood Pressure [<span class="nci">C25299</span>]</td></tr><tr class="tableroweven"><td>Pulse Rate [<span class="nci">C49676</span>]</td></tr><tr class="tablerowodd"><td>Height [<span class="nci">C25347</span>]</td></tr><tr class="tableroweven"><td>Systolic Blood Pressure [<span class="nci">C25298</span>]</td></tr><tr class="tablerowodd"><td>Temperature [<span class="nci">C25206</span>]</td></tr><tr class="tableroweven"><td>Weight [<span class="nci">C25208</span>]</td></tr></table></div><div class="codelist" id="CL.CL.VSTESTCD"><div class="codelist-caption">Vital Signs Test Code [<span class="nci">C66741</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Vital Signs Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DIABP [<span class="nci">C25299</span>]</td><td class="codelist-item-decode">Diastolic Blood Pressure</td></tr><tr class="tableroweven"><td>PULSE [<span class="nci">C49676</span>]</td><td class="codelist-item-decode">Pulse Rate</td></tr><tr class="tablerowodd"><td>HEIGHT [<span class="nci">C25347</span>]</td><td class="codelist-item-decode">Height</td></tr><tr class="tableroweven"><td>SYSBP [<span class="nci">C25298</span>]</td><td class="codelist-item-decode">Systolic Blood Pressure</td></tr><tr class="tablerowodd"><td>TEMP [<span class="nci">C25206</span>]</td><td class="codelist-item-decode">Temperature</td></tr><tr class="tableroweven"><td>WEIGHT [<span class="nci">C25208</span>]</td><td class="codelist-item-decode">Weight</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_BP"><div class="codelist-caption">Units for Vital Signs Results, subset for Blood Pressure [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Blood Pressure"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mmHg [<span class="nci">C49670</span>]</td><td class="codelist-item-decode">Millimeter of Mercury</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_BP_STD"><div class="codelist-caption">Units for Vital Signs Results, subset for Blood Pressure Std [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Blood Pressure Std"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>mmHg [<span class="nci">C49670</span>]</td><td class="codelist-item-decode">Millimeter of Mercury</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_HEIGHT"><div class="codelist-caption">Units for Vital Signs Results, subset for Height [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Height"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>in [<span class="nci">C48500</span>]</td><td class="codelist-item-decode">Inch</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_HEIGHT_STD"><div class="codelist-caption">Units for Vital Signs Results, subset for Height Std [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Height Std"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>cm [<span class="nci">C49668</span>]</td><td class="codelist-item-decode">Centimeter</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_PULSE"><div class="codelist-caption">Units for Vital Signs Results, subset for Pulse [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Pulse"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>beats/min [<span class="nci">C49673</span>]</td><td class="codelist-item-decode">Beats per Minute</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_PULSE_STD"><div class="codelist-caption">Units for Vital Signs Results, subset for Pulse Std [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Pulse Std"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>beats/min [<span class="nci">C49673</span>]</td><td class="codelist-item-decode">Beats per Minute</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_TEMP"><div class="codelist-caption">Units for Vital Signs Results, subset for Temperature [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Temperature"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>F [<span class="nci">C44277</span>]</td><td class="codelist-item-decode">Degree Fahrenheit</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_TEMP_STD"><div class="codelist-caption">Units for Vital Signs Results, subset for Temperature Std [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Temperature Std"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>C [<span class="nci">C42559</span>]</td><td class="codelist-item-decode">Degree Celsius</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_WT"><div class="codelist-caption">Units for Vital Signs Results, subset for Weight [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Weight"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>LB [<span class="nci">C48531</span>]</td><td class="codelist-item-decode">Pound</td></tr></table></div><div class="codelist" id="CL.CL.VS_UNIT_WT_STD"><div class="codelist-caption">Units for Vital Signs Results, subset for Weight Std [<span class="nci">C66770</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Units for Vital Signs Results, subset for Weight Std"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>kg [<span class="nci">C28252</span>]</td><td class="codelist-item-decode">Kilogram</td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br></div><a id="externaldictionary"></a><h1 class="invisible">External Dictionaries</h1><div class="containerbox"><table summary="External Dictionaries (MedDra, WHODRUG, ...)"><caption class="header">External Dictionaries</caption><tr class="header"><th scope="col">Reference Name</th><th scope="col">External Dictionary</th><th scope="col">Dictionary Version</th></tr><tr id="CL.CL.ISO21090" class="tablerowodd"><td>Null Flavors</td><td><a class="external" href="https://www.iso.org/standard/35646.html">ISO 21090 NullFlavor</a><span class="external-link-gif"></span> </td><td>2017</td></tr><tr id="CL.CL.ISO3166" class="tableroweven"><td>Country Codes</td><td><a class="external" href="https://www.iso.org/obp/ui/#search">ISO 3166-1 Alpha-3</a><span class="external-link-gif"></span> </td><td>2013-11-15</td></tr><tr id="CL.CL.MEDDRA" class="tablerowodd"><td>Adverse Events Dictionary</td><td><a class="external" href="https://www.meddra.org/">MedDRA</a><span class="external-link-gif"></span> </td><td>22.0</td></tr><tr id="CL.CL.SNOMED" class="tableroweven"><td>Trial Summary Medical Dictionary</td><td><a class="external" href="https://www.snomed.org/">SNOMED</a><span class="external-link-gif"></span> </td><td>2019-09-01</td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="compmethod"></a><div class="containerbox"><h1 class="invisible">Methods</h1><table summary="Methods"><caption class="header">Methods</caption><tr class="header"><th scope="col">Method</th><th scope="col">Type</th><th scope="col">Description</th></tr><tr id="MT.MT.AEENTPT" class="tablerowodd"><td>Algorithm to derive AEENTPT</td><td>Computation</td><td><div class="method-code">If AEENRTPT is populated, AEENTPT is DM.RFPENDTC for the subject.</div></td></tr><tr id="MT.MT.CMENTPT" class="tableroweven"><td>Algorithm to derive CMENTPT</td><td>Computation</td><td><div class="method-code">If CMENRTPT is populated, CMENTPT is DM.RFPENDTC for the subject.</div></td></tr><tr id="MT.MT.DAYCALC" class="tablerowodd"><td>Algorithm to derive DAYCALC</td><td>Computation</td><td><div class="method-code">Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC.</div></td></tr><tr id="MT.MT.DISEQ" class="tableroweven"><td>Algorithm to derive DISEQ</td><td>Computation</td><td><div class="method-code">Starts at "1" for first device identifier and increments by one for each DIPARM</div></td></tr><tr id="MT.MT.DTHFL" class="tablerowodd"><td>Algorithm to derive DTHFL</td><td>Computation</td><td><div class="method-code">If DTHDTC is populated then DTHFL='Y'</div></td></tr><tr id="MT.MT.EPOCH" class="tableroweven"><td>Algorithm to derive EPOCH</td><td>Computation</td><td><div class="method-code">EPOCH from SE where date &gt;= SESTDTC and date &lt; SEENDTC</div></td></tr><tr id="MT.MT.EXDOSE" class="tablerowodd"><td>Algorithm to derive EXDOSE</td><td>Computation</td><td><div class="method-code">EXDOSE = ECDOSE * ECPSTRG expressed in mg.</div></td></tr><tr id="MT.MT.FTSTRESN" class="tableroweven"><td>Algorithm to derive FTSTRESN</td><td>Computation</td><td><div class="method-code">If FTSTRESC is numeric then FTSTRESN=FTSTRESC in numeric format, else null.</div></td></tr><tr id="MT.MT.IEORRES" class="tablerowodd"><td>Algorithm to derive IEORRES</td><td>Computation</td><td><div class="method-code">If IECAT=INCLUSION then IEORRES=N, else if IECAT=EXCLUSION then IEORRES=Y</div></td></tr><tr id="MT.MT.LBSTRESC" class="tableroweven"><td>Algorithm to derive LBSTRESC</td><td>Computation</td><td><div class="method-code">LBSTRESC is equal to LBORRES or the value in standard units if a conversion is necessary.</div></td></tr><tr id="MT.MT.LOBXFL" class="tablerowodd"><td>Algorithm to derive LOBXFL</td><td>Computation</td><td><div class="method-code">Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise.</div></td></tr><tr id="MT.MT.QSSTRESC_PH" class="tableroweven"><td>Algorithm to derive QSSTRESC_PH</td><td>Computation</td><td><div class="method-code">If QSORRES="Not at all" then 0
If QSORRES="Several days" then 1
If QSORRES="More than half the days" then 2
If QSORRES="Nearly every day" then 3</div></td></tr><tr id="MT.MT.QSSTRESC_PH_10_11" class="tablerowodd"><td>Algorithm to derive QSSTRESC_PH_10_11</td><td>Computation</td><td><div class="method-code">QSSTRESC=QSORRES</div></td></tr><tr id="MT.MT.QSSTRESC_SL" class="tableroweven"><td>Algorithm to derive QSSTRESC_SL</td><td>Computation</td><td><div class="method-code">If QSORRES="Strongly disagree" then 1
If QSORRES="Disagree" then 2
If QSORRES="Slightly disagree" then 3
If QSORRES="Neither agree nor disagree" then 4
If QSORRES="Slightly agree" then 5
If QSORRES="Agree" then 6
If QSORRES="Strongly agree" then 7</div></td></tr><tr id="MT.MT.QSSTRESN" class="tablerowodd"><td>Algorithm to derive QSSTRESN</td><td>Computation</td><td><div class="method-code">If QSSTRESC is numeric then QSSTRESN=QSSTRESC in numeric format, else null.</div></td></tr><tr id="MT.MT.RFENDTC" class="tableroweven"><td>Algorithm to derive RFENDTC</td><td>Computation</td><td><div class="method-code">The Date of Study Completion or Early Termination. Null for screen failures.</div></td></tr><tr id="MT.MT.RFPENDTC" class="tablerowodd"><td>Algorithm to derive RFPENDTC</td><td>Computation</td><td><div class="method-code">The latest date of assessment for the subject as determined by the End of Study Form, any scheduled assessments, Adverse Events, or Concomitant Medications.</div></td></tr><tr id="MT.MT.RFSTDTC" class="tableroweven"><td>Algorithm to derive RFSTDTC</td><td>Computation</td><td><div class="method-code">The first date/time of study drug. Null for screen failures.</div></td></tr><tr id="MT.MT.RFXENDTC" class="tablerowodd"><td>Algorithm to derive RFXENDTC</td><td>Computation</td><td><div class="method-code">The last date/time of study drug administration. Null for subjects with no treatment data.</div></td></tr><tr id="MT.MT.RFXSTDTC" class="tableroweven"><td>Algorithm to derive RFXSTDTC</td><td>Computation</td><td><div class="method-code">The first date/time of study drug administration. Null for subjects with no treatment data.</div></td></tr><tr id="MT.MT.RSSTRESC" class="tablerowodd"><td>Algorithm to derive RSSTRESC</td><td>Computation</td><td><div class="method-code">RSSTRESC is the corresponding numeric value of RSORRES according the values shown on the HAMD-17 CRF page.</div></td></tr><tr id="MT.MT.SEENDTC" class="tableroweven"><td>Algorithm to derive SEENDTC</td><td>Computation</td><td><div class="method-code">SEENDTC is set to the start of the next Element, or RFPENDTC for the last Element.</div></td></tr><tr id="MT.MT.SEQ" class="tablerowodd"><td>Algorithm to derive SEQ</td><td>Computation</td><td><div class="method-code">Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data.</div></td></tr><tr id="MT.MT.SESTDTC" class="tableroweven"><td>Algorithm to derive SESTDTC</td><td>Computation</td><td><div class="method-code">SESTDTC if set to the --DTC for that subject which exists in the data for the defined start of the Element, such as DSSTDTC when DSDECOD=INFORMED CONSENT OBTAINED for Screening Elements or min(EXSTDTC) for Dosing Elements.</div></td></tr><tr id="MT.MT.STRESN" class="tablerowodd"><td>Algorithm to derive STRESN</td><td>Computation</td><td><div class="method-code">If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code.</div></td></tr><tr id="MT.MT.SVENDTC" class="tableroweven"><td>Algorithm to derive SVENDTC</td><td>Computation</td><td><div class="method-code">For each scheduled visit, SVENDTC = the last (max) date associated with a subject for that visit. For unplanned visits, SVENDTC is the date of the visit.</div></td></tr><tr id="MT.MT.SVSTDTC" class="tablerowodd"><td>Algorithm to derive SVSTDTC</td><td>Computation</td><td><div class="method-code">For each scheduled visit, SVSTDTC = the first (min) date associated with a subject for that visit. For unplanned visits, SVSTDTC is the date of the visit.</div></td></tr><tr id="MT.MT.TSSEQ" class="tableroweven"><td>Algorithm to derive TSSEQ</td><td>Computation</td><td><div class="method-code">Unique sequence number within each TSPARM, restarting at 1 for per TSPARM, applied to sorted data.</div></td></tr><tr id="MT.MT.VSSTRESC" class="tablerowodd"><td>Algorithm to derive VSSTRESC</td><td>Computation</td><td><div class="method-code">Data collected in conventional units (i.e. F, lbs, inches) is converted using standard conversion factors to standard units (C, kg, cm).</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br></div></body></html>